Physiologic Pacing Registry
Conditions: Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Ventricular Tachycardia, Heart Failure
Sponsor: Abbott Medical Devices

 
 
Physiologic Pacing Registry 
 
 
 
 
Version Number: C 
Date: June 9, 2020 
NCT Number: NCT03719040 
Sponsor: Abbott 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 2 of 3
 
 
TABLE OF CONTENTS 
 
1.0 
INTRODUCTION ............................................................................................................................................ 5 
1.1 
Background and Rationale ............................................................................................................................ 5 
 
Background ........................................................................................................................................... 5 
 
Rationale for Conducting this Clinical Registry ................................................................................... 7 
2.0 
CLINICAL REGISTRY OVERVIEW ............................................................................................................. 8 
2.1 
Objectives ..................................................................................................................................................... 8 
 
Primary objective .................................................................................................................................. 8 
2.2 
Device(s) To Be Used in the Clinical Registry ............................................................................................. 9 
 
Name of the Device(s) .......................................................................................................................... 9 
 
Intended Indication for Use .................................................................................................................. 9 
 
Description of the Device(s) ................................................................................................................. 9 
3.0 
REGISTRY DESIGN ..................................................................................................................................... 10 
3.1 
Overall Flow of the Clinical Registry and Follow-up Schedule ................................................................. 10 
3.2 
Suspension or Early Termination of the Clinical Registry ......................................................................... 11 
4.0 
ENDPOINTS .................................................................................................................................................. 12 
4.1 
Registry Outcome Measures ....................................................................................................................... 12 
5.0 
SUBJECT SELECTION AND WITHDRAWAL .......................................................................................... 13 
5.1 
Subject Population ...................................................................................................................................... 13 
5.2 
Subject Screening and Informed Consent ................................................................................................... 13 
 
Subject Screening ............................................................................................................................... 13 
 
Informed Consent ............................................................................................................................... 14 
5.3 
Eligibility Criteria ....................................................................................................................................... 15 
 
General Eligibility Criteria ................................................................................................................. 15 
 
Inclusion Criteria ................................................................................................................................ 15 
5.3.2.1 
General Inclusion Criteria ............................................................................................................... 15 
 
Exclusion Criteria ............................................................................................................................... 15 
5.3.3.1 
General Exclusion Criteria .............................................................................................................. 15 
5.4 
Subject Enrollment ..................................................................................................................................... 15 
5.5 
Subject Withdrawal ..................................................................................................................................... 16 
5.6 
Total Expected Duration of the Clinical Registry ....................................................................................... 17 
5.7 
Expected Duration of Each Subject’s Participation .................................................................................... 17 
5.8 
Number of Subjects Required for Inclusion in the Clinical Registry ......................................................... 17 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 3 of 4
 
 
5.9 
Estimated Time Needed to Select Required Number of Subjects .............................................................. 17 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS .............................................................................. 18 
6.1 
Baseline Clinical Assessments .................................................................................................................... 18 
6.2 
Implant Procedure ....................................................................................................................................... 18 
 
Unsuccessful Implants and Device Explants ...................................................................................... 19 
6.3 
Follow-up Assessments at 1 and 6 Months ................................................................................................. 20 
 
Unscheduled Visits ............................................................................................................................. 20 
 
Schedule of Events .............................................................................................................................. 21 
7.0 
ADVERSE EVENTS ...................................................................................................................................... 22 
7.1 
Definition .................................................................................................................................................... 22 
 
Adverse Event ..................................................................................................................................... 22 
 
Serious Adverse Event ........................................................................................................................ 22 
7.2 
Procedure and/or Device Relationship ........................................................................................................ 22 
7.3 
Adverse Event, Device Deficiency, and Complaint Reporting .................................................................. 22 
 
Adverse Event Reporting .................................................................................................................... 22 
 
Complaint Reporting ........................................................................................................................... 23 
 
Device Deficiency/Malfunction Reporting ......................................................................................... 23 
 
Procedure for Recording and Reporting Subject Death ...................................................................... 24 
8.0 
STATISTICAL CONSIDERATIONS............................................................................................................ 24 
8.1 
Analysis Populations ................................................................................................................................... 24 
8.2 
Statistical Analyses ..................................................................................................................................... 25 
 
Primary Outcome Measures Analyses ................................................................................................ 25 
8.3 
Sample Size Calculation and Assumptions ................................................................................................. 25 
8.4 
Timing of Analysis ..................................................................................................................................... 25 
8.5 
Subgroup Analysis ...................................................................................................................................... 25 
8.6 
Multiplicity ................................................................................................................................................. 25 
8.7 
Pooling Strategy .......................................................................................................................................... 25 
8.8 
Procedures for Accounting for Missing Data ............................................................................................. 25 
8.9 
Planned Interim Analysis ............................................................................................................................ 25 
8.10 
Statistical Criteria for Termination ............................................................................................................. 26 
8.11 
Success Criteria ........................................................................................................................................... 26 
8.12 
Labeling Claim ........................................................................................................................................... 26 
8.13 
Deviations from Statistical Plan.................................................................................................................. 26 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................................................. 26 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 4 of 5
 
 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE .............................................................................. 26 
10.1 
Selection of Clinical Sites and Investigators .............................................................................................. 26 
10.2 
Clinical Plan Amendments ......................................................................................................................... 26 
10.3 
Training ....................................................................................................................................................... 27 
 
Site Training ....................................................................................................................................... 27 
10.4 
Deviations from the Clinical Plan ............................................................................................................... 27 
10.5 
Monitoring .................................................................................................................................................. 27 
10.6 
Quality Assurance Audit ............................................................................................................................. 28 
11.0 
DATA HANDLING AND RECORD KEEPING .......................................................................................... 28 
11.1 
Protection of Personally Identifiable Information ...................................................................................... 28 
11.2 
Data Management Plan ............................................................................................................................... 29 
11.3 
Source Documentation ................................................................................................................................ 29 
11.4 
Electronic Case Report Form Completion .................................................................................................. 29 
11.5 
Record Retention ........................................................................................................................................ 29 
12.0 
ETHICAL CONSIDERATION ...................................................................................................................... 30 
12.1 
Institutional Review Board Review Approval ............................................................................................ 30 
13.0 
REGISTRY CONCLUSION .......................................................................................................................... 30 
14.0 
PUBLICATION POLICY .............................................................................................................................. 30 
15.0 
RISK ANALYSIS........................................................................................................................................... 31 
15.1 
Anticipated Clinical Benefits from Participating in this Clinical Registry ................................................. 31 
15.2 
Risks Associated with Participation in this Clinical Registry ..................................................................... 31 
15.3 
Steps Taken to Control or Mitigate Risks ................................................................................................... 31 
15.4 
Risk to Benefit Rationale of Treatment Under Study ................................................................................. 31 
APPENDIX I: Abbreviations and AcRonyms ............................................................................................................ 32 
APPENDIX II: Site Contact Information ................................................................................................................... 33 
APPENDIX III: Revision History .............................................................................................................................. 34 
APPENDIX IV: Summary .......................................................................................................................................... 35 
APPENDIX V: References ......................................................................................................................................... 39 
 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 5 of 6
 
 
COMPLIANCE STATEMENT:  
 
This registry will be conducted in accordance with this Clinical Plan, the Declaration of Helsinki, applicable Good 
Clinical Practices and regulations (e.g. US 21 CFR Part 50, 21 CFR Part 56, and OUS ISO14155:2011) and the 
appropriate local legislation(s). The most stringent requirements, guidelines or regulations must always be 
followed. The conduct of the registry will be approved by the appropriate Institutional Review Board (IRB)/Ethics 
Committee (EC) of the respective clinical site and by any applicable regulatory authorities.  
1.0 
INTRODUCTION 
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader 
understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing 
measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures 
prior to physiologic pacing device implants based on the clinical site’s routine care.  The registry will include 
patients undergoing implantation of an Abbott pacemaker, defibrillator, or a cardiac resynchronization therapy 
(CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site’s routine care.  Only 
patients scheduled to receive an Abbott device may be enrolled to ensure proper device data collection for future 
software and other physiologic pacing product development. The decision to provide physiologic pacing therapy 
and selection of devices for implant are at the discretion of the implanting physician. Abbott will collect data on the 
use of all commercially available leads and associated implant tools based on the physician’s discretion as part of 
routine clinical practice within the registry.   
 
This registry will be conducted in accordance with this Clinical Plan. All investigators involved in the conduct of 
the registry will be qualified by education, training, or experience to perform their tasks and this training will be 
documented appropriately. 
1.1 
Background and Rationale 
 
Background 
Patients with cardiac disease may exhibit symptoms associated with electrical conduction abnormalities, such as 
bradycardia and/or sinus node dysfunction, thereby requiring implantation of a permanent dual-chamber 
(atrioventricular) or single-chamber (ventricular) pacemaker.  However, these pacing modalities are associated with 
alteration of the normal electrical conduction due to right ventricular (RV) apical pacing,1,2,3 leading to accelerated 
progression of heart failure, and increasing the risk of heart failure hospitalization and atrial fibrillation.4,5  Patients 
with electrical conduction abnormalities may also present with associated ventricular dyssynchrony causing further 
cardiac disease progression into heart failure with impaired left ventricular function.6  The standard of care 
treatment for patients with ventricular dyssynchrony is implantation of a CRT system to activate the left ventricle 
and resynchronize the electrical conduction within the heart.  However, CRT is not always feasible due to difficulty 
in placing the left ventricular lead. Furthermore, the percentage of CRT non-responders remains high, up to 30-
40%.7,8 
 
An alternative and potentially more effective pacing strategy for patients with electrical conduction abnormalities is 
physiologic pacing. Physiologic pacing is achieved by delivering a pacing stimulus to a cardiac conduction 
structure, such as the bundle of His or left bundle branch (LBB) of the His-Purkinje system, with a permanent lead. 
Physiologic pacing activates the heart through the native His-Purkinje conduction system, thus offering the most 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 6 of 7
 
 
physiologic pacing approach to correct electrical dyssynchrony. Physiologic pacing has emerged as a feasible and 
safe alternative to pacemaker therapy and CRT with clinical and electrophysiological advantages. 
 
On such example of physiologic pacing includes activation of the His bundle.  The concept of His bundle pacing 
(HBP) was first described by Scherlag et al based on recruiting the heart’s native His-Purkinje system via pacing in 
both dogs and humans.9 Follow-up clinical studies demonstrated a more thorough understanding of the His bundle 
conduction system demonstrating that pacing distal to the site of conduction delay could recruit fibers predestined 
to be the bundle branches and thereby narrow the QRS duration in patients with bundle branch block.10,11,12  The 
next step of proving the viability of permanent HBP as a potential therapy was demonstrated in 2000 by Deshmukh 
et al. 13 in patients with normal His-Purkinje activation.  This first study of permanent HBP showed implant success 
in 12 of 18 patients (67%) with chronic atrial fibrillation after ablation of the atrioventricular junction.14,15 A 
subsequent study of permanent HBP several years later demonstrated a success rate of 65% in patients with AV 
block using standard pacing leads with retractable screws and manually shaped stylets.16 Likewise, early feasibility 
studies of HBP in patients meeting CRT indications have shown that patients have narrower paced QRS, (as 
compared to intrinsic or CRT paced), shorter implant times, improved quality of life, improved left ventricular 
ejection fraction (LVEF), and improved New York Heart Association (NYHA) classification 17,18,19 in lieu of a left 
ventricular lead.20 From these early studies, researchers found that QRS changes occur with different morphologies 
when undergoing permanent HBP 21,22, 23 and the morphology presentation is dependent upon: 1) the voltage output 
of the pulse generator 2) the anatomical position of the HBP lead and 3) the anatomical structure of the His bundle 
region.  Identification of the HBP morphology is important to locate the optimal lead implant location and pacing 
configuration. These three characteristics also play a key role in the degree of electrical capture during HBP, 
resulting in either selective (pure His-bundle capture) or non-selective (surrounding fibrous tissue also recruited 
along with His-bundle) pacing.   
 
Another example of physiologic pacing is direct stimulation of the left bundle branch (left bundle branch pacing – 
LBBP). Indirect stimulation of the left bundle branch was first demonstrated by El-Sherif et al 12 in CRT-indicated 
patients by using HBP and increasing the pacing output, thereby correcting left bundle branch block (LBBB). 
Direct LBBP was first reported by Huang et al 26, 27 during implant of a pacemaker in a patient with heart failure 
and LBBB. In this case, HBP with a high pacing output did not correct the LBBB but advancing the tip of the 
pacing lead to a more distal position did correct the LBBB at a lower pacing output. This resulted in a normalized 
QRS duration with prolonged AV delay, indicating synchronous LBBP with intrinsic RV stimulation was achieved. 
Similar to the reported effects of HBP, this patient saw significant improvement in their LVEF and significant 
reduction in heart failure symptoms. Based on these results, Huang et al proposed LBBP by stimulating distal to the 
diseased region for patients with heart failure and LBBB. Several subsequent studies have shown LBBP to be a safe 
and feasible pacing method not only for this patient population but also for patients with bradycardia. 28 - 36 Similar 
to HBP, LBBP capture can be either selective or non-selective. Confirmation of LBB capture is typically verified 
by QRS morphology changes from LBB pacing, identification of the LBB potential recorded from the pacing lead, 
selective capture with specific ECG changes and EGM component, and evaluation of the time from pacing stimulus 
to LV activation. 38, 39 Other methods of activating the left bundle branch through indirect stimulation are emerging 
and may be assessed through this registry as well. 
 
One major goal of physiologic pacing is to provide a consistent reduction in QRS duration. Physiologic pacing 
provides an opportunity to ensure the normalization of the QRS; however, many technical challenges remain, 
including: lead delivery, accurate His-Purkinje capture (selective vs. non-selective), and maintenance of stable 
pacing thresholds over time.  The data collected from this registry will offer further evidence on the utility of 
physiologic pacing implants and currently available tools, as well as the potential advantages of enhanced 
localization of physiologic pacing structures using a 3-dimensional mapping system.  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 7 of 8
 
 
 
Rationale for Conducting this Clinical Registry 
In the recent recommendations from the His Bundle Pacing Collaborative Working group24, the authors suggested 
that technical challenges of achieving permanent HBP has been an obstacle to its reliable application in routine 
clinical practice. These technical challenges include difficulty in locating and placing a pacing lead at the 
appropriate His bundle location due to its small size and the surrounding fibrous tissue. There are additional 
concerns related to maintaining chronic pacing due to high thresholds and lead dislodgement. Pacing the LBB as 
known today has similar challenges in locating and navigating the pacing lead to a small target. 
The Physiologic Pacing Registry will be conducted to gain a deeper understanding of device implants for 
physiologic pacing and follow-up workflows, including the use of any lead delivery tools, to help inform Abbott’s 
product and clinical data development efforts. Additionally, the registry will provide a broader understanding of the 
clinical utility in mapping cardiac conduction structures, such as the bundle of His and Left Bundle Branch, with 
the use of Abbott’s EnSite Cardiac Mapping System with an electrophysiology catheter prior to device implants for 
those institutions where mapping is routine care prior to a physiologic pacing device implant.  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 8 of 9
 
 
2.0 
CLINICAL REGISTRY OVERVIEW 
2.1 
Objectives 
 
Primary objective  
The Physiologic Pacing Registry will characterize implant and follow-up measures associated with physiologic 
pacing device implants.  The registry will also compare implant and follow-up characteristics for these device 
implants with and without utilizing the EnSite Cardiac Mapping System, based on the site’s routine care.  Data on 
all tools used as chosen by the physician as part of their standard practice will be collected. Abbott will collect data 
on the following characteristics at implant and follow-up:  
 
Implant Characteristics: 
 
Fluoroscopy time and radiation dose 
 
Overall procedure time: skin-to-skin  
 
Implant procedure time: vascular access to lead fixation 
 
All implant tools used 
 
Implant-related workflow 
 
Final implanted hardware  
 
Final post-procedure device programming 
 
Procedure- and device-related adverse events and device deficiencies 
 
Implant success 
 
All types of physiologic pacing capture observed such as selective and non-selective 
 
Physiologic pacing capture and sensing thresholds 
 
Pacing output necessary to correct bundle branch block using 12-lead ECG (if applicable) 
 
Presenting QRS duration at baseline using 12-lead ECG 
 
QRS duration for all types of physiologic pacing captures observed using 12-lead ECG 
 
For His placement only: Measured H wave using device intracardiac electrogram (IEGM)  
 
Measured R wave using device IEGMs through the lead implanted for physiologic pacing  
 
Follow-up Characteristics: 
 
Follow-up related workflow 
 
Physiologic pacing capture and sensing thresholds 
 
For His placement only: Measured H wave using device IEGM 
 
Measured R wave using device IEGMs through the lead implanted for physiologic pacing  
 
Presenting PR interval and QRS duration using 12-lead ECG 
 
QRS duration for all types of physiologic pacing captures observed using 12-lead ECG 
 
Incidence of increase in capture threshold of > 1V in leads implanted for physiologic pacing or RV pacing 
leads  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 9 of 10
 
 
 
Far-field atrial oversensing and ventricular oversensing and/or any interventions – including programming 
– required to address these issues  
 
NYHA Classification 
 
LVEF, Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) 
(if available)  
 
Tricuspid and mitral regurgitation severity by echocardiogram (if available) 
 
Device estimated battery longevity via device session records 
 
Frequency/burden of detected atrial and ventricular arrhythmias via device session records 
 
Procedure and device-related adverse events and device deficiencies 
2.2 
Device(s) To Be Used in the Clinical Registry 
 
Name of the Device(s)  
Table 1 outlines the devices that will be used. The devices selected for use will be at the discretion of the 
implanting physician. 
Table 1: Devices Used in the Registry 
Device name 
Model/Type 
Manufacturer 
Region/ 
Country 
Investigational or 
Market Released 
Any Abbott market-
approved pacemaker, 
defibrillator, and/or CRT 
device 
Any market-
approved models 
St. Jude 
Medical 
All 
geographies
Market released 
Any market-approved 
pacing, defibrillation, 
and/or CRT lead(s) 
Any market-
approved models 
All 
All 
geographies
Market released 
EnSite Cardiac Mapping 
System 
(optional) 
Any market-
approved models 
St. Jude 
Medical 
All 
geographies
Market released 
Merlin Patient Care 
System 
v19.1.1 or later 
St. Jude 
Medical 
All 
geographies
Market released 
Delivery Catheter and 
other implant tools 
Any market-
approved model 
All 
All 
geographies
Market released 
 
Intended Indication for Use 
All devices used in this registry are market released. Refer to the specific device IFU for the indications for use. 
 
Description of the Device(s)  
Please refer to the Indications for Use for additional information regarding the devices used in this registry. 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 11 of 12
 
 
 
Figure 1: Clinical Registry Flow Chart  
3.2 
Suspension or Early Termination of the Clinical Registry 
No formal statistical rule for early termination of the registry is defined.  
The Sponsor reserves the right to discontinue the registry at any stage or reduce the follow-up period with suitable 
written notice to the investigator. Possible reason(s) may include, but are not limited to: 
 
Subject safety  
 
Further product development cancelled 
 
If the registry is discontinued by the Sponsor, subjects will be followed per routine hospital practice with device-
related adverse events reported to the Sponsor as per vigilance/commercial reporting requirements. 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 12 of 13
 
 
 
Should this occur, the investigator shall return all unused registry materials to the Sponsor and provide a written 
statement as to why the premature termination has taken place to the EC/IRB (if applicable). All applicable registry 
documents shall be subject to the same retention policy as detailed in Section 11.0.  
 
A Principal Investigator, EC/IRB, or regulatory authority may suspend or prematurely terminate participation in 
this registry at the clinical sites for which they are responsible. The investigators will follow the requirements 
specified in the Clinical Trial Agreement.  
 
If the Sponsor suspends or prematurely terminates the registry at an individual site in the interest of safety, the 
Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing resources to fulfill 
the obligations from the Clinical Plan and existing agreements for following the subjects enrolled in the registry, 
and the Principal Investigator or authorized designee will promptly inform the enrolled subjects at his/her site, if 
appropriate. 
4.0 
ENDPOINTS 
4.1 
Registry Outcome Measures 
The Physiologic Pacing Registry will collect data on the following measures as recommended by the His Bundle 
Pacing Collaborative Working group17 to characterize the workflow associated with physiologic pacing device 
implants and follow-up, and to quantify the clinical utility of mapping the cardiac structures prior to physiologic 
pacing device implants according to sites’ routine care. Implant and follow-up characteristics will be compared 
with and without utilizing the EnSite Cardiac Mapping System during device implants. 
 
Implant Characteristics: 
 
Fluoroscopy time and radiation dose 
 
Overall procedure time: skin-to-skin  
 
Implant procedure time: vascular access to lead fixation 
 
All implant tools used   
 
Implant-related workflow 
 
Final implanted hardware  
 
Final post-procedure device programming 
 
Procedure- and device-related adverse events and device deficiencies 
 
Implant success 
 
All types of physiologic pacing capture observed such as selective and non-selective 
 
Physiologic pacing capture and sensing thresholds  
 
Pacing output necessary to correct bundle branch block using 12-lead ECG (if applicable) 
 
QRS duration at baseline and following implant using 12-lead ECG  
 
QRS duration for all types of physiologic pacing captures observed using 12-lead ECG 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 13 of 14
 
 
 
For His placement only: Measured H wave using device IEGM  
 
Measured R wave using device IEGMs through the lead implanted for physiologic pacing 
 
Follow-up Characteristics: 
 
Follow-up related workflow 
 
Physiologic pacing capture and sensing thresholds  
 
For His placement only: Measured H wave using device IEGM 
 
Measured R wave using device IEGMs through the lead implanted for physiologic pacing 
 
Presenting PR interval and QRS duration using 12-lead ECG 
 
QRS duration for all types of physiologic pacing captures observed using 12-lead ECG 
 
Incidence of increase in capture threshold of > 1V in leads implanted for physiologic pacing or RV pacing 
leads  
 
Far-field atrial oversensing and ventricular oversensing and/or any interventions – including programming 
– required to address these issues  
 
NYHA Classification 
 
LVEF, LVEDV, LVESV (if available) 
 
Tricuspid and mitral regurgitation severity by echocardiogram (if available) 
 
Device estimated battery longevity via device session records 
 
Frequency/burden of detected atrial and ventricular arrhythmias via device session records 
 
Procedure and device-related adverse events 
5.0 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 
Subject Population 
The patient population for this registry is potential subjects undergoing implantation of an Abbott pacemaker, 
defibrillator, or CRT-P/D with any market released pacing lead as part of a physiologic pacing procedure according 
to the clinical site’s routine care. The decision to provide physiologic pacing therapy and selection of devices for 
implant are at the discretion of the implanting physician. 
This registry will consecutively approach patients scheduled to receive an Abbott device to enroll male and female 
subjects who are eligible for the above-mentioned device implant. Subjects must meet all eligibility criteria and 
provide written informed consent prior to conducting any registry-specific procedures not considered standard of 
care.  
5.2 
Subject Screening and Informed Consent 
 
Subject Screening 
Members of the site’s research team (physician and/or research coordinator, or other delegated and qualified 
personnel) previously trained to this Clinical Plan must screen potential patients for eligibility and should document 
screening efforts onto a site-specific screening log. Patients who meet the inclusion criteria and none of the 
exclusion criteria may participate in this registry.  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 14 of 15
 
 
 
Potential patients meeting inclusion criteria and no exclusion criteria will be fully informed about the registry, 
following the established informed consent process (described in Section 5.2.2). They will be asked to sign an 
Informed Consent form if they wish to participate in the registry. These patients should also be entered onto the 
site-specific screening log. 
 
Once a duly dated and signed Informed Consent form is obtained, the registry-specific screening procedures may 
begin.  
The following assessments are performed as part of the screening process: 
 
Medical History  
 
Cardiovascular Baseline Measures   
Subject data will be collected following enrollment into the registry. 
 
Informed Consent 
The Patient Informed Consent form must receive approval from the Sponsor and EC/IRB prior to beginning 
registry enrollment.   
 
The Investigator or his/her authorized designee will conduct the Informed Consent process, as required by 
applicable regulations and the center’s EC/IRB. This process will include a verbal discussion with the patient on all 
aspects of the registry that are relevant to the patient’s decision to participate, such as details of registry procedures, 
anticipated benefits, and potential risks of registry participation. Patients must be informed about their right to 
withdraw from the registry at any time and for any reason without sanction, penalty or loss of benefits to which the 
patient is otherwise entitled. Withdrawal from the registry will not jeopardize their future medical care or 
relationship with the investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper influence 
on the patient and will respect the patient’s legal rights. The patient shall be provided with the Informed Consent 
form written in a language that is understandable to the patient and has been approved by the center’s EC/IRB. The 
patient shall have adequate time to review, ask questions and consider participation. If the patient agrees to 
participate, the Informed Consent form must be signed and dated by the patient and thereafter by the person 
obtaining the consent prior to any registry-specific procedures. The signed original will be filed in the subject’s 
hospital or research charts, and a copy will be provided to the subject. 
 
In addition, an authorization for use and disclosure of the subject’s protected health information, in accordance with 
the Health Insurance Portability and Accountability Act (HIPAA), must be obtained from the subjects or their legal 
representative. 
 
Failure to obtain informed consent from a subject prior to enrollment should be reported to the Sponsor within 5 
working days and to the reviewing center’s EC/IRB according to the EC/IRB’s reporting requirements. 
 
If, during the registry, new information becomes available that can significantly affect a subject's future health and 
medical care, the Principal Investigator or his/her authorized designee will provide this information to the subject. 
If relevant, the subject will be asked to confirm their continuing informed consent in writing. 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 15 of 16
 
 
Vulnerable Populations 
Vulnerable populations will not be enrolled in the Physiologic Pacing Registry.  
5.3 
Eligibility Criteria 
 
General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a candidate 
patient. If some of the clinical and laboratory tests are not included in the site’s standard tests, they must be done 
after written informed consent is obtained. Patients must meet ALL the inclusion criteria to be considered for the 
registry. If ANY of the exclusion criteria are met, the patient is excluded from the registry and cannot be enrolled. 
 
Inclusion Criteria 
5.3.2.1 General Inclusion Criteria 
Subjects must meet all the following inclusion criteria for enrollment in the registry. 
1. Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D device with any 
commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site’s 
routine care.  
2. At least 18 years of age. 
3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 
4. Provided written informed consent prior to any registry-related procedures. 
 
Exclusion Criteria 
5.3.3.1 General Exclusion Criteria 
Subjects will be excluded from enrollment if any of the exclusion criteria is met below. 
1. History of tricuspid valve repair or replacement. 
2. Currently participating in another clinical study with an active treatment arm and belong to the active arm 
3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions 
that, in the investigator’s opinion, could limit the subject’s ability to participate in the registry or to comply 
with follow-up requirements, or impact the scientific soundness of the registry results. 
4. Chronic physiologic pacing lead implanted 
5. Life expectancy of < 6 months. 
6. Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of 
the subclavian vein, etc.). 
5.4 
Subject Enrollment 
A patient is considered enrolled in the registry once he/she meets eligibility requirements and has signed the 
informed consent form.  Subjects who have a successful implant and are later found to have met exclusion criteria 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
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Page 16 of 17
 
 
or not all inclusion criteria will continue follow-up in the registry and will be included in the enrolled population; a 
protocol deviation will be completed for these subjects. 
5.5 
Subject Withdrawal 
Each enrolled subject shall remain in the registry until completion of the required follow-up period; however, a 
subject’s participation in any registry is voluntary and the subject has the right to withdraw at any time without 
penalty or loss of benefit. Conceivable reasons for discontinuation may include, but not be limited to, the following: 
 
Subject death 
 
Subject voluntary withdrawal  
 
Subject withdrawal by physician as clinically-indicated 
 
Subject lost-to follow-up as described below  
 
The Sponsor must be notified of the reason(s) for subject discontinuation. The site will provide this information to 
the Sponsor. Investigators must also report this to their respective EC/IRB as defined by their institution’s 
procedure(s).  No additional follow–up will be required or data recorded from subjects once withdrawn from the 
registry. The status of the subject’s condition should be documented at the time of withdrawal. 
 
Before the subject is withdrawn from the registry the site should make attempts to schedule the subject for a final 
registry follow-up visit. At this final follow-up visit, the subject will undergo the following assessments with 
documentation completed on the unscheduled follow-up form: 
 
Follow-up related workflow 
 
Physiologic pacing capture and sensing thresholds   
 
For His placement only - Measured H wave using device IEGM  
 
Measured R wave using device IEGMs through the lead implanted for physiologic pacing 
 
QRS duration for all physiologic pacing captures observed using 12-lead ECG 
 
PR interval using 12-lead ECG 
 
Incidence of increase in capture threshold of > 1V in the lead implanted for physiologic pacing or RV 
pacing leads  
 
Far-field atrial oversensing and ventricular oversensing and/or any interventions – including programming 
– required to address these issues  
 
NYHA Classification 
 
LVEF, LVEDV, LVESV (if available) 
 
Tricuspid and mitral regurgitation severity by echocardiogram (if available) 
 
Device estimated battery longevity via device session records 
 
Frequency/burden of detected atrial and ventricular arrhythmias via device session records 
 
Procedure and device-related adverse events and device deficiencies 
 
Lost-to-Follow-up 
If the subject misses the scheduled 1-month follow-up time point and the attempts at contacting the subject detailed 
below are unsuccessful, then the subject is considered lost-to-follow-up. Site personnel shall make all reasonable 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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6.0 
TREATMENT AND EVALUATION OF ENDPOINTS 
6.1 
Baseline Clinical Assessments 
Patients will undergo screening evaluations as outlined by the inclusion/exclusion criteria. The Principal Investigator 
(PI) or delegated research personnel are responsible for screening all potential patients to determine eligibility for the 
registry. All patients will complete a Baseline visit within 60 days prior to implant. During this visit, eligible patients 
will sign an EC/IRB-approved Informed Consent form. Once informed consent has been obtained, sites will collect 
the following data at the Baseline visit: 
 
Subject demographics 
 
Subject medical history  
 
Physical examination  
 
Cardiovascular history 
 
Indications for device implant  
 
LVEF, LVEDV, LVESV (if available)  
 
Tricuspid valve regurgitation and Mitral valve regurgitation severity by echo (if available) 
 
Intrinsic QRS duration using 12-lead ECG 
 
PR interval using 12-lead ECG 
 
Baseline conduction pattern using 12-lead ECG  
 
NYHA Classification 
 
Sites must complete and submit the associated Baseline Visit Case Report Forms (CRFs) to Abbott using the 
electronic data capture (EDC) system. 
6.2 
Implant Procedure 
Investigators should follow their standard implant technique and workflow for physiologic pacing procedures and 
the associated devices indications for use. The decision to provide physiologic pacing therapy and selection of 
devices for implant are at the discretion of the implanting physician. Only subjects scheduled to receive an Abbott 
device may be enrolled to ensure proper device data collection for future software and other physiologic pacing 
product development; however, the investigator may use any market-approved lead and associated implant tools.  If 
part of their routine clinical practice in physiologic pacing implants, physicians may create a 3-dimensional map of 
cardiac structures using any diagnostic mapping catheter with the EnSite Cardiac Mapping System.   
 
Sites will collect the following data during the implant procedure:  
 
Fluoroscopy time and radiation dose 
 
Overall procedure time: skin-to-skin  
 
Implant procedure time: vascular access to lead fixation 
 
All Implant tools used 
 
Implant-related workflow 
 
Final implanted hardware  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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6.3 
Follow-up Assessments at 1 and 6 Months 
The schedule of follow-up visits is based on the date of the successful implant of a lead for physiologic pacing with 
Abbott device implant. Table 2 outlines the time window permitted for each of the registry visits. 
 
 
Table 2: Registry Time Interval Windows 
1 Month  
6 Months 
-14 days/+30 days   
± 60 days 
 
Sites will follow all subjects at 1 month and 6 months after the date of successful HBP lead and Abbott device 
implant.  
 
During each follow-up visit, the following data will be collected: 
 
Follow-up related workflow 
 
Physiologic pacing capture and sensing thresholds  
 
For His placement only: Measured H wave using device IEGM  
 
Measured R wave using device IEGMs through lead implanted for physiologic pacing 
 
Presenting QRS duration and PR interval from 12-lead ECG 
 
QRS duration for all types of physiologic pacing captures observed from 12-lead ECG 
 
Incidence of increase in capture threshold of > 1V in leads implanted for physiologic or RV pacing leads  
 
Far-field atrial oversensing and ventricular oversensing and/or any interventions – including programming 
– required to address these issues  
 
NYHA Classification 
 
LVEF, LVEDV, LVESV (if available) 
 
Tricuspid and mitral regurgitation severity by echocardiogram (if available) 
 
Device estimated battery longevity via device session records 
 
Frequency/burden of detected atrial and ventricular arrhythmias via device session records 
 
Procedure and device-related adverse events and device deficiencies 
 
Sites must download the device session records and submit to Abbott using the EDC system. Sites must also submit 
copies of the subject’s physiologic pacing 12-lead ECGs in digital format (if available).   Sites must complete and 
submit the associated Follow-up visit CRFs to Abbott using the EDC system. 
 
Sponsor Representatives may provide support during the follow-up procedures for device-related data collection.  
 
Unscheduled Visits 
An unscheduled visit is defined as a visit between two registry-required visits during which the clinical site 
performs a device interrogation and reprogramming. Sites should download device session records and 12-lead 
ECGs (if available) and submit to Abbott using the EDC system. Sites must complete and submit the associated 
Follow-up visit CRFs, and any other applicable CRFs to Abbott using the EDC system. 

ABT-CIP-10270 Ver. C
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Physiologic Pacing Registry 
Clinical Plan 
 
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Schedule of Events 
Table 3: Schedule of Events 
CIP Activity 
Baseline  
(≤ 60 days prior   
to implant)
Implant  
 
1-Month  
(-14/+30 days post 
successful implant)
6- Month 
(±60 days post 
successful implant) 
Unscheduled 
Informed Consent Process 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Physical Examination 
X 
 
X 
X 
X 
Cardiovascular History 
X 
 
 
 
 
Implant indication 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
NYHA Class 
X 
 
X 
X 
X 
Implant Data Collection (Section 6.2) 
 
X 
 
 
 
System Information 
 
X 
 
 
 
Device Interrogation 
 
X 
X 
X 
X 
Device Programming 
 
X 
X 
X 
X 
12-lead ECG 
X 
X* 
X 
X 
X 
For His placement only: Measured H 
wave using device IEGM  
 
X 
X 
X 
X 
Measured R wave using device IEGMs 
through physiologic pacing lead 
 
X 
X 
X 
X 
Electro-anatomical Mapping (optional) 
 
(X) 
 
 
 
LVEF (if available) 
X 
 
 
X 
 
Follow-up Data Collection (Section 6.3) 
 
 
X 
X 
 
Device Session Records 
 
X 
X 
X 
X 
Adverse Event 
(X) 
(X) 
(X) 
(X) 
(X) 
Device Deficiency 
 
(X) 
(X) 
(X) 
(X) 
Deviation 
(X) 
(X) 
(X) 
(X) 
(X) 
Termination 
(X) 
(X) 
(X) 
(X) 
(X) 
Assessment for Hospitalization 
 
 
X 
X 
X 
Death 
(X) 
(X) 
(X) 
(X) 
(X) 
Product Out of Service 
 
 
(X) 
(X) 
(X) 
(X) if applicable; *If available 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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7.0 
ADVERSE EVENTS 
To comply with worldwide standards and guidelines on adverse event reporting, Abbott has adopted uniform and 
worldwide applicable standard definitions and reporting timelines to be used and adhered to by the investigators.  
7.1 
Definition 
 
Adverse Event 
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical 
device under investigation. 
Note: This definition includes events related to the procedures involved. 
 
Serious Adverse Event 
If the adverse event meets any of the criteria below, it is regarded as a serious adverse event.  
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent impairment 
to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a serious 
deterioration in health, is not considered to be a serious adverse event. 
7.2 
Procedure and/or Device Relationship 
Determination of whether there is a reasonable possibility that the procedure and/or device involved in the registry 
caused or contributed to an adverse event is to be determined by the Investigator and recorded on the appropriate 
electronic CRF form. Determination should be based on assessment of temporal relationships, evidence of 
alternative etiology, medical/biologic plausibility, and patient condition (pre-existing condition). 
7.3 
Adverse Event, Device Deficiency, and Complaint Reporting 
 
Adverse Event Reporting 
General Adverse Event Reporting 
Safety surveillance and reporting starts as soon as the patient has an attempted implant in the registry. An attempted 
implant is defined as insertion of the physiologic pacing lead into vasculature. Safety surveillance and reporting 
will continue until the last follow-up visit has been performed, the subject is deceased, the subject concludes 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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Page 23 of 24
 
 
participation in the registry, or the subject withdraws from the registry. Sites will collect all serious adverse events 
(including all deaths) and all adverse events related to the procedure and/or device, whether serious or not, 
throughout the time period defined above and will report to the Sponsor on a CRF. Additional information 
regarding an adverse event should be updated within the appropriate CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not adverse events and should not be reported.  
An off-line form will be made available to allow the investigator to report serious adverse events in the event the 
entry cannot be made in the EDC. This does not replace the EDC reporting system. All information must still be 
entered in the EDC system as soon as feasible.  
 
Serious Adverse Event Reporting 
The investigator will report all serious adverse events, including all deaths, to the Sponsor as soon as possible but 
no later than outlined below.  
 
Clinical Site 
Reporting timelines 
All Sites 
All serious adverse events must be reported to the Sponsor no later than 3 calendar days 
from the day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined. 
 
The date the site staff became aware the event met the criteria of a serious adverse event must be recorded in the 
source document.  The Investigator will further report the serious adverse event to the local EC/IRB according to 
the institution’s EC/IRB reporting requirements. 
 
Complaint Reporting 
During the registry, the investigator will be responsible for reporting all complaints. A complaint is defined as any 
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, 
reliability, safety, effectiveness or performance of a device after it is released for distribution. 
 
If the complaint does not involve an adverse event, the investigator must notify the Post-Market Surveillance 
Department by submitting the information on the device via email to 
as soon as possible after becoming aware of the complaint. This information will not be collected on a CRF 
for the registry. 
 
If the complaint involves an adverse event, the investigator must complete an Adverse Event CRF, including the 
information on the complaint and submit to the Sponsor as soon as possible. 
 
 
Device Deficiency/Malfunction Reporting  
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This includes 
the failure of the device to meet its performance specifications or otherwise perform as intended. Note: performance 
specifications include all claims made in the labeling of the device. 
A device malfunction is the failure of a device to meet its performance specifications or otherwise perform as 
intended, when used in accordance with the instructions for use or CIP. 

ABT-CIP-10270 Ver. C
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Physiologic Pacing Registry 
Clinical Plan 
 
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Sites should report all device deficiencies/malfunctions for any Abbott product used to the Sponsor on the 
appropriate CRF form. The investigator must report all device deficiencies/malfunctions to the Sponsor as soon as 
possible but no later than outlined below.  
 
Clinical Sites 
Reporting timelines 
All Sites 
Device deficiencies/malfunctions for any Abbott product used must be reported to 
the Sponsor no later than 3 calendar days from the day the site personnel became 
aware of the event or as per the investigative site’s local requirements, if the 
requirement is more stringent than those outlined.
Sites should return all devices to the Sponsor which are not implanted or not remaining in the subject.  In addition, 
sites should report device deficiencies/malfunctions to the IRB/EC per the investigative site’s local requirements. 
The Sponsor will provide an offline form to allow the investigator to report device deficiencies/malfunctions if the 
entry cannot be made in the EDC system. This does not replace the EDC reporting system.  Sites must continue to 
enter all information in the EDC system as soon as feasible.  
 
Procedure for Recording and Reporting Subject Death 
For all deaths, the investigator should record death information in the hospital records and immediately document 
the information on the Adverse Event CRF and submit to Sponsor. 
The investigator should make all efforts to obtain details about the circumstances surrounding the subject death. 
 
A subject’s death is an early conclusion of the subject’s participation in the registry. Therefore, the Investigator is 
required to complete the Withdrawal CRF. 
 
Sites should report all death events as per the serious adverse event reporting requirements stated in the ‘Adverse 
Event Reporting Requirements’ section (7.3.1). 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
Analysis Populations 
The analysis populations include:  
1. Enrollment population: includes all subjects enrolled in the registry.  
2. Implanted population: includes subjects enrolled in the registry, implanted with Abbott device, and have an 
active (programmed on) lead implanted for physiologic pacing post implant. 
Additional analysis populations will be defined in a separate statistical analysis plan as appropriate. 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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8.10 
Statistical Criteria for Termination 
 
8.11 
Success Criteria 
 
8.12 
Labeling Claim  
 
8.13 
Deviations from Statistical Plan 
Any major changes to the statistical plan will be documented in an amendment to the statistical plan. Minor 
changes to the planned analyses will be documented in the final report.   
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for the purpose of performing 
registry-related monitoring, audits, EC/IRB review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow monitors or regulatory authorities to review, in 
confidence, any records identifying the subjects in this registry. This information may be shared with regulatory 
agencies; however, the Sponsor undertakes not to otherwise release the subject's personal and private information. 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 
Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the registry. Sites will be 
selected based upon review of a recent site assessment, if applicable, and the qualifications of the Principal 
Investigator or multidisciplinary team at the site. 
10.2 
Clinical Plan Amendments  
The Sponsor will provide approved Clinical Plan amendments to the investigators prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the EC/IRB or equivalent committee of the 
amendment (administrative changes) or obtaining EC/IRB’s approval of the amendment (changes in subject care or 
safety), according to the instructions provided by the Sponsor with the amendment.   
 
Acknowledgement/approval by the EC/IRB of the Clinical Plan amendment must be documented in writing prior to 
implementation of the amendment. Copies of this documentation must also be provided to the Sponsor. 

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Physiologic Pacing Registry 
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10.3 
Training 
 Site Training 
All investigators and research personnel are required to attend Sponsor training sessions, which may be conducted 
at an Investigator's meeting, a site training visit, or other appropriate training sessions. Over-the-phone or self-
training may take place as required. Training of investigators and research personnel will include, but is not limited 
to, the Clinical Plan requirements, electronic CRF completion, and research personnel responsibilities. All 
investigators and research personnel that are trained must sign a training log (or an equivalent) upon completion of 
the training. Prior to signing the training log, investigators and research personnel must not perform any registry-
related activities that are not considered standard of care at the site.  
10.4 
Deviations from the Clinical Plan 
The Investigator should not deviate from the Clinical Plan for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety and well-being of the subject or eliminate an apparent 
immediate hazard to the subject. In that event, the Investigator will notify the Sponsor immediately by phone or in 
writing.  
 
No waivers for protocol deviations will be granted by the Sponsor.  All protocol deviations must be reported to the 
Sponsor using the Deviation CRF. The occurrence of deviations will be monitored by the Sponsor for evaluation of 
investigator compliance to the Clinical Plan and regulatory requirements and dealt with according to written 
procedures. Investigators will inform their EC/IRB or equivalent committee of all deviations in accordance with 
their specific EC/IRB or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or company 
representative will attempt to secure compliance by one or more of the following (and not limited to):  
 Visiting the investigator and/or delegate 
 Telephoning the investigator and/or delegate 
 Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the Clinical Plan or any other conditions of the registry may 
result in further escalation in accordance with the Sponsor’s written procedures, including securing compliance or, 
at its sole discretion, the Sponsor may terminate the investigator's participation in the registry.  
10.5 
Monitoring 
The Sponsor and/or designee will monitor the registry using a risk-based strategy according to the study-specific 
monitoring plan which will include the extent of source data verification.  
Prior to initiating any procedure, the Sponsor’s monitor (or delegate) will ensure the following criteria are met:  
• The Investigator understands and accepts the obligation to conduct the registry according to the Clinical 
Plan and applicable regulations and has signed the Investigator Agreement.   
• The Investigator and his/her staff should have sufficient time and facilities to conduct the registry and should 
have access to an adequate number of appropriate subjects to conduct the registry.  

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Physiologic Pacing Registry 
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• Source documentation (including original medical records) must be available to substantiate proper 
informed consent procedures, adherence to Clinical Plan procedures, adequate reporting and follow-up of 
adverse events, accuracy of data collected on case report forms, and device information. 
 The Investigator/site will permit access to such records. A monitoring visit sign-in log will be maintained at 
the site. The Investigator will agree to dedicate an adequate amount of time to the monitoring process. The 
Investigator and/or research coordinator will be available for monitoring visits. It is expected that the 
Investigator will provide the monitor with a suitable working environment for review of Clinical Plan-
related documents. 
10.6 
Quality Assurance Audit 
A Sponsor representative or designee may request access to all registry records, including source documentation, 
for inspection during a Quality Assurance audit.  
 
In the event an Investigator is contacted by a Regulatory Agency in relation to this registry, the Investigator will 
notify the Sponsor immediately. The Investigator and Research Coordinator must be available to respond to 
reasonable requests and audit queries made during the audit process. The Investigator must provide the Sponsor 
with copies of all correspondence that may affect the review of the current registry (e.g., Form FDA 483, 
Inspectional Observations, Warning Letters, Inspection Reports, etc.).  The Sponsor may provide any needed 
assistance in responding to regulatory audits. 
11.0 
DATA HANDLING AND RECORD KEEPING  
The Sponsor and/or its affiliates will include documentation of the systems and procedures used in data collection 
for the duration of the registry.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will access the 
EDC system using a unique username and password to enter, review or correct data. Passwords and electronic 
signatures will be strictly confidential.    
 
The data will be subjected to consistency and validation checks within the EDC system and supplemental review by 
the Sponsor. 
 
At the conclusion of the registry, completed CRF images with the date-and-time stamped electronic audit trail 
indicating the user, the data entered, and any reason for change (if applicable) will be provided to the clinical sites, 
if requested.  
 
For the duration of the registry, the Investigator will maintain complete and accurate documentation including, but 
not limited to, medical records, registry progress records, laboratory reports, electronic CRFs, signed Informed 
Consent forms, correspondence with the EC/IRB and Sponsor, adverse event reports, and information regarding 
subject discontinuation or completion of the registry. 
11.1 
Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this registry. The 
privacy of each subject and confidentiality of his/her information will be preserved in reports and when publishing 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
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consent of Abbott.
 
Page 29 of 30
 
 
any data. Confidentiality of data will be observed by all parties involved at all times throughout the registry. All 
data will be secured against unauthorized access. 
11.2 
Data Management Plan 
A Data Management Plan will describe procedures used for data review, database cleaning, and issuing and 
resolving data queries. If appropriate, the Data Management Plan may be updated throughout the duration of the 
registry. All revisions will be tracked and document controlled. 
11.3 
Source Documentation 
 
Regulations and Good Clinical Practice require the Investigator to maintain information in the subject’s original 
medical records that corroborates data collected on the CRFs. In order to comply with these regulatory 
requirements/Good Clinical Practice, the following information should be included in the subject record at a 
minimum: 
 
Medical history/physical condition of the subject before involvement in the registry sufficient to verify the 
Clinical Plan entry criteria 
 
Dated and signed notes on the day of entry into the registry referencing the Sponsor, Clinical Plan number, 
subject ID number and a statement that informed consent was obtained 
 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
 
Procedure and device-related adverse events reported and their resolution, including supporting documents, 
such as discharge summaries, catheterization laboratory reports, ECGs, and lab results including 
documentation of site awareness of serious adverse events and of investigator assessment of device 
relationship for serious adverse events. 
 
Device session records 
 
Subject’s condition upon completion of or withdrawal from the registry 
 
Any other data required to substantiate data entered into the CRF 
11.4 
Electronic Case Report Form Completion  
Primary data collection based on source-documented hospital and/or clinic chart reviews will be performed clearly 
and accurately by site personnel trained on the Clinical Plan and electronic CRF completion. Data from electronic 
CRFs will be collected for all subjects enrolled into the registry.  The Investigator will ensure accuracy, 
completeness, legibility and timeliness of the data reported to the Sponsor on the CRFs and in all required reports. 
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed by the 
Sponsor. An electronic audit trail will be used to track any subsequent changes of the entered data. 
11.5 
Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the registry as per the 
applicable regulatory record retention requirements. The Investigator must obtain permission from Sponsor in 
writing before destroying or transferring control of any registry records. 
 

ABT-CIP-10270 Ver. C
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Physiologic Pacing Registry 
Clinical Plan 
 
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12.0 
ETHICAL CONSIDERATION 
 
12.1 
Institutional Review Board Review Approval 
EC/IRB approval for the Clinical Plan and Informed Consent form/other written information provided to the patient 
will be obtained by the Principal Investigator at each clinical site prior to consenting and enrolling patients in this 
registry. The approval letter must be received prior to the start of this registry and a copy must be provided to the 
Sponsor.  
 
Any amendments to the Clinical Plan as well as associated Informed Consent form changes will be submitted to the 
EC/IRB and written approval obtained prior to implementation, according to each institution’s EC/IRB 
requirements.  
 
No changes will be made to the Clinical Plan or Informed Consent form or other written information provided to 
the patient without appropriate approvals, including EC/IRB, the Sponsor, and the regulatory agencies (if 
applicable).  
 
Until the registry is completed, the Investigator will advise his/her EC/IRB of the progress of this registry, per 
EC/IRB requirements. Written approval must be obtained from the EC/IRB yearly to continue the registry, or 
according to each institution’s EC/IRB requirements.  
 
No investigative procedures other than those defined in this Clinical Plan will be undertaken on the enrolled 
subjects without the written agreement of the EC/IRB and the Sponsor. 
13.0 
REGISTRY CONCLUSION 
The registry will conclude when: 
 
All sites are closed AND 
 
The final report has been provided to investigators or the Sponsor has provided formal documentation of 
registry closure. 
14.0 
PUBLICATION POLICY 
The data and results from the registry are the sole property of the Sponsor. The Sponsor shall have the right to 
access and use all data and results generated during the registry. The investigators will not use this registry-related 
data without the written consent of the Sponsor for any purpose other than for registry completion or for generation 
of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be 
published or presented before the multi-center results. Any proposals for publications or presentations by the 
investigators must be reviewed and approved by the Sponsor in a timely manner to enable Sponsor review in 
compliance with the Sponsor’s publication policy set forth in the Clinical Trial Agreement. 
 
The Sponsor will register the study on www.clinicaltrials.gov and will be responsible for posting results as required 
by the ClinicalTrials.gov website. 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 31 of 32
 
 
15.0 
RISK ANALYSIS 
 
Patients participating in this registry are indicated for a pacemaker, defibrillator, or CRT device as part of their 
standard medical management and are subject to the risks associated with these devices.  Risks associated with the 
specified device and procedure, together with their likely incidence, are described in the individual device 
Indications for Use.  There may be risks related to the devices used in the registry that are unknown at present.  
Likewise, the exact frequency of the risk may be unknown. 
15.1 
Anticipated Clinical Benefits from Participating in this Clinical Registry 
Patients participating in this registry have the same clinical benefit as any patient receiving a pacemaker, 
defibrillator, or CRT device. Participation in this registry is not required in order for a patient to receive 
physiological pacing therapy.  
 
Data collected in this study will help to understand device use and implantation procedures for physiologic pacing 
therapy. Data collected will also be used to inform future Abbott product development.     
15.2 
Risks Associated with Participation in this Clinical Registry 
All procedures required by this registry are standard of care according to each individual clinical site’s practice.  
There are no anticipated risks associated with participation in this registry or any risks beyond those identified in 
the individual device Indication for Use. 
15.3 
Steps Taken to Control or Mitigate Risks 
Physicians participating in this registry will be selected based on their education, training, or experience in 
performing physiologic pacing procedures.  Therefore, physicians are expected to be aware of the known and 
foreseeable safety risks associated with the use of the devices, including the surgical and/or non-surgical treatment 
of these conditions.  The procedures outlined in this Clinical Plan are all standard of care according to the 
individual clinical site’s practice.  Additionally, clinical sites will report all procedure and device-related adverse 
events to the Sponsor – all adverse events will be monitored internally for safety surveillance purposes. 
15.4 
Risk to Benefit Rationale of Treatment Under Study 
The risks associated with the registry are in line with the risks associated with a standard of care implant of a 
cardiac pacemaker, defibrillator, or CRT device.  There are potential unknown risks of physiologic pacing 
associated with the lead implant procedure and long-term follow-up. Patients are indicated for an implant of a 
cardiac device and will undergo the implant based on the clinical site’s standard of care.  As such, patients 
participating in this registry have the same clinical benefit as those patients receiving a pacemaker, defibrillator, or 
CRT device.  There are potential benefits from receiving physiologic pacing. These benefits include the potential 
for sustained or improved ventricular function, as well as the potential benefits gained by the enhanced 
visualization and localization of cardiac conduction structures prior to implant of a permanent lead for physiologic 
pacing.  Based on this information, the Sponsor believes the benefits outweigh the risks associated with 
participation in the registry. 
 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
Template: 86357 Rev. E 
Page 32 of 33
 
 
 
APPENDIX I: ABBREVIATIONS AND ACRONYMS 
AE: Adverse Event 
AV: Atrioventricular 
CRT: Cardiac Resynchronization Therapy 
CRT-D: Cardiac Resynchronization Therapy Defibrillator 
CRT-P: Cardiac Resynchronization Therapy Pacemaker 
CRF: Case Report Form 
EC: Ethics Committee 
ECG: Electrocardiogram 
EDC: Electronic Data Capture 
FDA: Food and Drug Administration 
HBP: His Bundle Pacing 
HIPAA: Health Insurance Portability and Accountability Act 
IEGM: Intracardiac Electrogram 
IRB: Institutional Review Board 
LBBP: Left Bundle Branch Pacing 
LVEF: Left Ventricular Ejection Fraction 
LVESV: Left Ventricular End Systolic Volume 
LVEDV: Left Ventricular End Diastolic Volume 
NYHA: New York Heart Association 
PI: Principal Investigator 
RV: Right Ventricular  
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 35 of 36
 
 
APPENDIX IV: SUMMARY 
Registry Name 
Physiologic Pacing Registry 
Title 
Physiologic Pacing – Post Market Registry 
Purpose 
The Physiologic Pacing Registry will be conducted to gain a deeper understanding of 
physiologic pacing device implants and follow-up workflows, including device and 
programmer measurements to help inform Abbott’s product and clinical data 
development efforts. Additionally, the registry will provide a broader understanding of 
the clinical utility in mapping physiologic pacing structures with the use of Abbott’s 
EnSite Cardiac Mapping System with an electrophysiology catheter prior to device 
implants for those institutions where mapping is routine care prior to physiologic pacing 
device implant.  
Objective(s) 
The Physiologic Pacing Registry will characterize implant and follow-up measures 
associated with physiologic pacing device implants.  The registry will also compare 
implant and follow-up characteristics for implants performed with and without utilizing 
the EnSite Cardiac Mapping System. 
Devices Included in 
Registry 
Any market-approved Abbott pacemaker, defibrillator, or CRT device 
Any market-approved implant tools 
EnSite Cardiac Mapping System (optional)
 
Number of Subjects 
Required  
 
Registry Design 
This registry is designed as a prospective, non-randomized, multi-center registry. The 
registry will enroll patients scheduled for implant with an Abbott device with any 
available lead and associated implant tools – this is to ensure proper device data 
collection for future software and other physiologic pacing product development.   
Prior to device implant, investigators may perform a comprehensive electrophysiology 
study and/or create a 3-dimensional electro-anatomical map of physiologic pacing 
structures based on their site’s routine care using any diagnostic mapping catheter with 
the EnSite Cardiac Mapping System. 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 36 of 37
 
 
Primary Outcomes 
Measure(s) 
The Physiologic Pacing Registry will collect data on the following measures to 
characterize the workflow associated with physiologic pacing device implants and 
follow-up, and to quantify the clinical utility of mapping the physiologic pacing 
structures prior to implants according to sites’ routine care. Implant and follow-up 
characteristics will be compared with and without utilizing the EnSite Cardiac Mapping 
System during device implants. 
 
Implant Characteristics: 
 
Fluoroscopy time and radiation dose 
 
Overall procedure time: skin-to-skin  
 
Implant procedure time: vascular access to lead fixation 
 
All implant tools used  
 
Implant-related workflow 
 
Final implanted hardware  
 
Final post-procedure device programming 
 
Procedure- and device-related adverse events, and device deficiencies 
 
Implant success 
 
All types of physiologic pacing capture observed such as selective and non-
selective 
 
Physiologic pacing capture and sensing thresholds   
 
Pacing output necessary to correct bundle branch block using 12-lead ECG (if 
applicable) 
 
QRS duration for all types of physiologic pacing captures observed using 12-
lead ECG 
 
For His placement only: Measured H wave using device intracardiac 
electrogram (IEGM)  
 
Measured R wave using device IEGMs through physiologic pacing lead 
 
Follow-up Characteristics: 
 
Follow-up related workflow 
 
Physiologic pacing capture and sensing thresholds  
 
For His placement only: Measured H wave using device IEGM   
 
Measured R wave using device IEGMs through physiologic pacing lead 
 
QRS duration for all types of physiologic pacing captures observed using 12-
lead ECG 
 
Presenting QRS Duration and PR interval using 12-lead ECG 
 
Incidence of increase in capture threshold of > 1V in physiologic or RV pacing 
leads  

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 37 of 38
 
 
 
Far-field atrial oversensing and ventricular oversensing and/or any 
interventions – including programming – required to address these issues  
 
NYHA Classification 
 
LVEF, LVEDV, LVESV (if available) 
 
Tricuspid and mitral regurgitation severity by echocardiogram (if available) 
 
Device estimated battery longevity via device session records 
 
Frequency/burden of detected atrial and ventricular arrhythmias via device 
session records 
 
Procedure and device-related adverse events, and device deficiencies 
Subject Follow-up 
The subjects will be followed in-clinic at baseline (before implant), implant, and at 1 
month and 6 months after the date of successful implant. 
 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 38 of 39
 
 
Inclusion Criteria 
 
Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D 
device with a pacing lead located at a physiologic pacing structure according to the 
clinical site’s standard of care 
 
At least 18 years of age 
 
Willing and able to comply with the prescribed follow-up tests and schedule of 
evaluations 
 
Provided written informed consent prior to any registry-related procedure
Exclusion Criteria 
 
History of tricuspid valve repair or replacement 
 
Currently participating in another clinical study with an active treatment arm and 
belong to the active arm 
 
Presence of other anatomic or comorbid conditions, or other medical, social, or 
psychological conditions that, in the investigator’s opinion, could limit the 
subject’s ability to participate in the registry or to comply with follow-up 
requirements, or impact the scientific soundness of the registry results 
 
Chronic physiologic pacing lead implanted 
 
Life expectancy of < 6 months 
 
Known contraindication for a physiologic pacing implant (i.e. ongoing infection, 
known occlusion of the subclavian vein, etc.)
 
 
 
 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 39 of 40
 
 
APPENDIX V: REFERENCES 
 
1.  Adomian GE, Beazell J. Myofibrillar disarray produced in normal hearts by chronic electrical pacing. Am Heart 
J. 1986;112:79–83. 
 
2.  Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and 
dyssynchrony implications for therapy. J Am Coll Cardiol. 2009;54:764–776. doi: 10.1016/j.jacc.2009.06.006. 
 
3. Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA, Investigators 
MOST. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal 
baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation Jun 17 
2003;107:2932-2937. 
 
4.  Zhang XH1, Chen H, Siu CW, Yiu KH, Chan WS, Lee KL, Chan HW, Lee SW, Fu GS, Lau CP, Tse HF. New-
onset heart failure after permanent right ventricular apical pacing in patients with acquired high-grade 
atrioventricular block and normal left ventricular function J Cardiovasc Electrophysiol. 2008 Feb;19(2):136-41. 
Epub 2007 Nov 12. 
 
5. Merchant FM, Hoskins MH, Musat DL, Prillinger JB, Roberts GJ, Nabutovsky Y, Mittal S. Incidence and Time 
Course for Developing Heart Failure With High-Burden Right Ventricular Pacing. Circ Cardiovasc Qual Outcomes. 
2017 Jun;10(6). pii: e003564. doi: 10.1161/CIRCOUTCOMES.117.003564 
  
6.  Bleeker GB, Schalij MJ, Molhoek SG, Verwey HF, Holman ER, Boersma E, Steendijk P, Van Der Wall EE, 
Bax JJ. Relationship between QRS duration and left ventricular dyssynchrony in patients with end-stage heart 
failure. J Cardiovasc Electrophysiol May 2004;15:544-549. 
 
7. Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, Leon AR, Oshinski JN. 
Agreement is poor among current criteria used to define response to cardiac resynchronization therapy. Circulation 
May 11 2010;121:1985-1991. 
 
8. Birnie DH, Tang AS. The problem of non-response to cardiac resynchronization therapy. Curr Opin Cardiol Jan 
2006;21:20-26.  
 
9.  Scherlag BJ, Kosowsky BD, Damato AN. A technique for ventricular pacing from the His bundle of the intact 
heart. J Appl Physiol Mar 1967;22:584-587. 
 
10. Narula OS, Scherlag BJ, Javier RP, Hildner FJ, Samet P. Analysis of the A-V conduction defect in complete 
heart block utilizing His bundle electrograms. Circulation Mar 1970;41:437-448.  
 
11. Narula OS. Longitudinal dissociation in the His bundle. Bundle branch block due to asynchronous conduction 
within the His bundle in man. Circulation Dec 1977;56:996-1006.  
 
12. El-Sherif N, Amay YLF, Schonfield C, Scherlag BJ, Rosen K, Lazzara R, Wyndham C. Normalization of 
bundle branch block patterns by distal His bundle pacing. Clinical and experimental evidence of longitudinal 
dissociation in the pathologic his bundle. Circulation Mar 1978;57:473-483. 
 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 40 of 41
 
 
 
13.  Deshmukh P, Casavant DA, Romanyshyn M, Anderson K. Permanent, direct His-bundle pacing: a novel 
approach to cardiac pacing in patients with normal His-Purkinje activation. Circulation Feb 29 2000;101:869-877. 
 
14.  Barba-Pichardo R, Morina-Vazquez P, Venegas-Gamero J, Maroto-Monserrat F, Cid-Cumplido M, Herrera-
Carranza M. [Permanent His-bundle pacing in patients with infra-Hisian atrioventricular block]. Rev Esp Cardiol 
Jun 2006;59:553-558. 
 
15.  Occhetta E, Bortnik M, Magnani A, Francalacci G, Piccinino C, Plebani L, Marino P. Prevention of ventricular 
desynchronization by permanent para-Hisian pacing after atrioventricular node ablation in chronic atrial fibrillation: 
a crossover, blinded, randomized study versus apical right ventricular pacing. J Am Coll Cardiol May 16 
2006;47:1938-1945. 
 
16.  Barba-Pichardo R, Morina-Vazquez P, Fernandez-Gomez JM, Venegas-Gamero J, Herrera-Carranza M. 
Permanent His-bundle pacing: seeking physiological ventricular pacing. Europace Apr 2010;12:527-533. 
 
17. Lustgarten DL, Calame S, Crespo EM, Calame J, Lobel R, Spector PS. Electrical resynchronization induced by 
direct His-bundle pacing. Heart Rhythm. 2010 Jan;7(1):15-21. doi: 10.1016/j.hrthm.2009.09.066. Epub 2009 Oct 6. 
 
18. Lustgarten DL, Crespo EM, Arkhipova-Jenkins I, Lobel R, Winget J, Koehler J, Liberman E, Sheldon T.  His-
bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design 
comparison. Heart Rhythm. 2015 Jul;12(7):1548-57. doi: 10.1016/j.hrthm.2015.03.048. Epub 2015 Mar 28. 
 
19. Teng AE, Lustgarten DL, Vijayaraman P, Tung R, Shivkumar K1, Wagner GS, Ajijola OA. Am J Cardiol. 2016 
Aug 15;118(4):527-34. doi: 10.1016/j.amjcard.2016.05.049. Epub 2016 May 28. Usefulness of His Bundle Pacing 
to Achieve Electrical Resynchronization in Patients With Complete Left Bundle Branch Block and the Relation 
Between Native QRS Axis, Duration, and Normalization. 
 
20. Ajijola OA, Upadhyay GA, Macias C, Shivkumar K, Tung R3. Permanent His-bundle pacing for cardiac 
resynchronization therapy: Initial feasibility study in lieu of left ventricular lead. Heart Rhythm. 2017 
Sep;14(9):1353-1361. doi: 10.1016/j.hrthm.2017.04.003. Epub 2017 Apr 8.  
 
21. Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, Vijayaraman P. Permanent 
His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. Heart 
Rhythm Feb 2015;12:305-312. 
 
22.  Upadhyay GA, Tung R. J Electrocardiol. 2017 Mar - Apr;50(2):191-194. doi: Selective versus non-selective 
his bundle pacing for cardiac resynchronization therapy. 10.1016/j.jelectrocard.2016.10.003. Epub 2016 Oct 18. 
 
23.  Teng AE1, Massoud L1, Ajijola OA2. Physiological mechanisms of QRS narrowing in bundle branch block 
patients undergoing permanent His bundle pacing. J Electrocardiol. 2016 Sep-Oct;49(5):644-8. doi: 
10.1016/j.jelectrocard.2016.07.013. Epub 2016 Jul 16. 
 
24.  Vijayaraman P, Dandamudi G, Zanon F, Sharma PS, Tung R, Huang W, Koneru J, Tada H8, Ellenbogen KA, 
Lustgarten DL. Permanent His bundle pacing: Recommendations from a Multicenter His Bundle Pacing 
 

ABT-CIP-10270 Ver. C
Study Name: Physiologic Pacing Registry
Physiologic Pacing Registry 
Clinical Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott.
 
Page 41 of 41
 
 
 
Collaborative Working Group for standardization of definitions, implant measurements, and follow-up. Heart 
Rhythm. 2018 Mar;15(3):460-468. doi: 10.1016/j.hrthm.2017.10.039. Epub 2017 Oct 28. 
 
26. Huang W, Su L, Wu S, et al. A novel pacing strategy with low and stable output: Pacing the left bundle branch 
immediately beyond the conduction block. Can J Cardiol 2017;33:1736. e1–3. 
 
27. Zhang s, Zhou X, Gold M. Left bundle branch pacing: JACC review topic of the week. J Am Coll Cardiol 
2019;74:3039–49. 
 
28. Sharma PS, Dandamudi G, Herweg B, et al. Permanent His-bundle pacing as an alternative to biventricular 
pacing for cardiac resynchronization therapy: a multicenter experience. Heart Rhythm 2018;15:413–20. 
 
29. Huang W, Su L, Wu S, et al. Long-term outcomes of His bundle pacing in patients with heart failure with left 
bundle branch block. Heart 2019; 105:137–43. 
 
30. Hou X, Qian Z, Wang Y, et al. Feasibility and cardiac synchrony of permanent left bundle branch pacing 
through the interventricular septum. Europace 2019; 21: 1694–1702. 
 
31. Li Y, Chen K, Dai Y, et al. Left bundle branch pacing for symptomatic bradycardia: implant success rate, safety 
and pacing characteristics. Heart Rhythm 2019 May 22 [E-pub ahead of print]. 
 
32. Li X, Li H, Ma W, et al. Permanent left bundle branch area pacing for atrioventricular block: feasibility, safety 
and acute effect. Heart Rhythm 2019 Apr 29 [E-pub ahead of print]. 
 
33. Vijayaraman P, Naperkowski A, Subzposh F, et al. Prospective evaluation of feasibility, electrophysiologic 
and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm 2019 May 25 [E-pub ahead 
of print]. 
 
34. Zhang W, Huang J, Qi Y, et al. Cardiac resynchronization therapy by left bundle branch area pacing in heart 
failure patients with left bundle branch block. Heart Rhythm 2019 Sept 9 [E-pub ahead of print]. 
 
35. Zou J, Jiang Z, Qian Z, et al. Cardiac electrical and mechanical synchrony of peri-left bundle branch pacing. 
Circulation 2018;138:A15153. 
 
36. Chen K, Li Y, Dai Y, et al. Comparison of electrocardiogram characteristics and pacing parameters between left 
bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace 2019; 24:673–
80. 
 
37. Chen K, Li Y. How to implant left bundle branch pacing lead in route clinical practice. J Cardiovasc 
Electrophysiol 2019;30:2569–77. 
 
38. Huang W, Chen X, Su L, et al. A beginner’s guide to permanent left bundle branch pacing. Heart Rhythm 2019 
June 22 [E-pub ahead of print]. 
 
39. Chen X, Wu S, Su L, et al. The characteristics of the electrocardiogram and the intracardiac electrogram in left 
bundle branch pacing. J Cardiovasc Electrophysiol 2019;30:1096–101.