Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry
Conditions: Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Heart Failure
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express 
written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
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NCT Number: 05887323 
 
LBBAP Data Collection Registry 
Study Document No: 
 
Version B 
Date: 02-JUL-2024 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
15900 Valley View Ct. 
      
  
 
 
Sylmar, CA 91342  
        
 
 
 
USA 
 
 
 

 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

 
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TABLE OF CONTENTS 
 
1.0 
INTRODUCTION ................................................................................................................ 7 
1.1 
Background and Rationale ........................................................................................................... 7 
 
Background ............................................................................................................................... 7 
 
Rationale for Conducting this Clinical Investigation .................................................................. 8 
2.0 
CLINICAL INVESTIGATION OVERVIEW ........................................................................... 8 
2.1 
Clinical Investigation Objective ..................................................................................................... 8 
2.2 
Device(s) Used in the Clinical Investigation .................................................................................. 8 
 
Name of the Device(s) Under Investigation .............................................................................. 8 
 
Indication for Use/Intended Purpose ......................................................................................... 9 
 
Description of the Device(s) Under Investigation ...................................................................... 9 
3.0 
CLINICAL INVESTIGATION DESIGN ................................................................................ 9 
3.1 
Clinical Investigation Procedures and Follow-up Schedule .......................................................... 9 
3.2 
Measures Taken to Avoid and Minimize Bias and Achieve Systemic Data Collection ............... 10 
3.3 
Suspension or Early Termination of the Clinical Investigation .................................................... 11 
 
Subject Follow-up for Early Termination or Suspension of Registry ....................................... 11 
4.0 
ENDPOINTS ..................................................................................................................... 11 
4.1 
Primary Safety Endpoint and Rationale ...................................................................................... 11 
4.2 
Primary Effectiveness Endpoint and Rationale ........................................................................... 12 
4.3 
Descriptive Endpoints ................................................................................................................. 12 
5.0 
SUBJECT SELECTION AND WITHDRAWAL .................................................................. 13 
5.1 
Subject Population ...................................................................................................................... 13 
5.2 
Subject Screening and Informed Consent .................................................................................. 13 
 
Subject Recruitment and Screening ........................................................................................ 13 
 
Informed Consent ................................................................................................................... 13 
5.3 
Eligibility Criteria ......................................................................................................................... 14 
 
General Eligibility Criteria ........................................................................................................ 14 
 
Inclusion Criteria ..................................................................................................................... 14 
 
Exclusion Criteria .................................................................................................................... 14 
5.4 
Subject Enrollment ..................................................................................................................... 15 
5.5 
Subject Withdrawal and Discontinuation .................................................................................... 15 

 
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9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS .................................................... 22 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE ..................................................... 22 
10.1 
Selection of Clinical Sites and Investigators ............................................................................... 22 
10.2 
Site Principal Investigator Responsibilities ................................................................................. 23 
10.3 
Clinical Investigation Finances and Agreements ........................................................................ 23 
10.4 
CIP Amendments........................................................................................................................ 23 
10.5 
Training ....................................................................................................................................... 23 
 
Site Training ............................................................................................................................ 23 
10.6 
Monitoring ................................................................................................................................... 24 
10.7 
Deviations from CIP .................................................................................................................... 24 
10.8 
Quality Assurance Audit ............................................................................................................. 25 
10.9 
Sponsor Auditing ........................................................................................................................ 25 
11.0 
DATA HANDLING AND RECORD KEEPING ................................................................ 25 
11.1 
Protection of Personally Identifiable Information ........................................................................ 26 
11.2 
Data Management Plan .............................................................................................................. 26 
11.3 
Source Documentation ............................................................................................................... 26 
11.4 
Case Report Form Completion ................................................................................................... 27 
11.5 
Record Retention ........................................................................................................................ 27 
12.0 
ETHICAL CONSIDERATION ......................................................................................... 27 
12.1 
Institutional Review Board/Medical Ethics Committee Review and Approval ............................. 27 
13.0 
CLINICAL INVESTIGATION CONCLUSION ................................................................. 28 
14.0 
PUBLICATION POLICY ................................................................................................. 28 
15.0 
RISK ANALYSIS ............................................................................................................ 29 
APPENDIX I: ABBREVIATIONS AND ACRONYMS ................................................................... 30 
APPENDIX II: SITE CONTACT INFORMATION ........................................................................ 31 
APPENDIX III: LABELS .............................................................................................................. 32 
APPENDIX IV: CASE REPORT FORMS .................................................................................... 33 
APPENDIX V: MONITORING PLAN ........................................................................................... 34 
APPENDIX VI: REVISION HISTORY ......................................................................................... 35 
APPENDIX VII: CIP SUMMARY ................................................................................................. 36 
APPENDIX VIII: REFERENCES ................................................................................................. 38 

 
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COMPLIANCE STATEMENT:  
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the 
Declaration of Helsinki, applicable Good Clinical Practices and regulations (e.g., US 21 CFR Part 50, 21 
CFR Part 56, 21 CFR Part 812 and OUS ISO14155:2020) and the appropriate local legislation(s). The 
most stringent requirements, guidelines or regulations must always be followed. The conduct of the 
clinical investigation will be approved by the appropriate Institutional Review Board (IRB)/Ethics 
Committee (EC) of the respective investigational site and by the applicable regulatory authorities (e.g., 
FDA, PMDA, MHRA, etc.). 
 
 

 
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1.0 
INTRODUCTION 
This registry is a retrospective, observational, non-controlled chart review conducted to support an 
indication expansion of the Tendril STS 2088 lead to include pacing/sensing in the left bundle branch 
area.  
This clinical investigation will be conducted in accordance with this CIP. All investigators involved in the 
conduct of the clinical investigation 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 (sinus node dysfunction and/or heart block), 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) pacing,1-3 leading to accelerated progression of left ventricular dysfunction, 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 desynchrony causing further 
cardiac disease progression into heart failure with impaired left ventricular function.6 
 
Physiological pacing achieved by His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP) 
has emerged as an alternative pacing strategy for patients with pacemaker indications. While HBP can 
be considered an ideal form of physiological pacing as it activates the heart through the native His-
Purkinje conduction system resulting in synchronized contraction of the ventricles obviating RV pacing-
related complications, its widespread clinical utility has been limited by technical challenges including 
lead delivery, accurate His-bundle capture (selective vs. non-selective), and early battery depletion due 
to high pacing thresholds over time. Left bundle branch area pacing (LBBAP), on the other hand, has 
been suggested as an effective alternative to overcome the limitations of HBP attributed to the anatomic 
and histological characteristics of the LBB.7  
 
The left bundle branch (LBB) is surrounded by dense myocardial tissue providing a large target zone for 
pacing owing to its thick, band-like structure.7 Moreover, the LBB can be activated from the main trunk, 
the posterior fascicle or the septal fascicle.7, 8 Therefore, LBBAP presents a lesser technical challenge 
compared to HBP.  
 
In regard to clinical outcome, it has been reported that LBBAP provides stable and reliable lead 
parameters at short and intermediate follow-up.8-11 The need for a back-up RV lead is deemed 
unnecessary and device programming is simplified.8, 12 Furthermore, reported complication rates of the 
1343 published cases remain low with LBBAP,13 and increased threshold at follow-up is infrequent 
thereby minimizing the need for lead revision.14 Improvements on clinical outcomes of LBBAP compared 
to RVP has been further demonstrated by Sharma et al. using results from the Geisinger-Rush 
Conduction System Pacing Registry with a large multicenter cohort.  It has been concluded that LBBAP 
was associated with a significant reduction in the composition outcome of all-cause mortality, heart 
failure or upgrade to bi-ventricular pacing.15   
 

 
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 Rationale for Conducting this Clinical Investigation 
LBBAP has emerged as a feasible and safe alternative to traditional pacing modalities with clinical and 
electrophysiological advantages. This is a retrospective, observational, non-controlled chart review real-
world evidence registry to evaluate the safety and effectiveness of LBBA pacing/sensing in patients 
already implanted with the Tendril STS 2088 lead. The LBBAP data collection registry is designed to 
support future indication expansion of the existing Tendril STS 2088TC lead to include conduction 
system pacing in the left bundle branch area (LBBAP). This LBBAP data collection registry is designed in 
accordance with FDA’s guidance documents: Considerations for the Use of Real-World Data and Real-
World Evidence To Support Regulatory Decision-Making for Drug and Biological Products – December 
2021 and Considerations for the Use of Real-World Evidence to Support Regulatory Decision-Making for 
Medical Devices – August 2017. Tendril STS 2088TC bradycardia lead is currently market approved 
under P960013/S46 on May 26, 2009 and CE-marked under CE Cert no. 17 09 01 14607 104 on June 
16, 2009, and is indicated for permanent sensing and pacing in either the right atrium or the right 
ventricle in combination with a compatible pacemaker, implantable cardioverter defibrillator (ICD) or 
cardiac resynchronization therapy (CRT-P/CRT-D) device.  
2.0 
CLINICAL INVESTIGATION OVERVIEW 
2.1 
Clinical Investigation Objective 
The objective of this LBBAP data collection registry is to evaluate the safety and effectiveness of LBBA 
pacing/sensing in patients already implanted with the Tendril STS 2088 lead. 
2.2 
Device(s) Used in the Clinical Investigation 
 Name of the Device(s) Under Investigation 
Table 1 outlines the devices included in the registry.  
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  
Abbott/St. 
Jude Medical 
All 
geographies Market released 
Any market-approved 
pacing, defibrillation, 
and/or CRT lead(s) – 
non-LBBAP lead 
Any market-
approved models 
All 
All 
geographies Market released 
Abbott market-
approved lead(s) 
implanted in LBBAP 
location 
TendrilTM STS 
2088 
Abbott/St. 
Jude Medical 
All 
geographies Market released 

 
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• 
Sites should retain an enrollment log which links the subject ID and identifiable information for 
traceability purposes in order to address inquiries from regulatory agencies, as needed.  
• 
Sites should review patient medical records (i.e., electronic health records) and submit only de-
identified data through Case Report Forms (CRFs). 
• 
Sites should make all the effort to collect both successful and unsuccessful LBBAP implantation 
attempts for the time being applicable to the purpose of this registry by utilizing a device inventory 
list and/or sales data relevant to the usage of the TendrilTM STS 2088 lead. 
• 
Monitoring by the sponsor will be conducted using a risk-based approach to maintain the 
reliability and data integrity of the data included in this registry (see details in section 10.6).  
3.3 
Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient 
effectiveness of the device under investigation is defined, the Sponsor reserves the right to discontinue 
the clinical investigation 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: 
• 
Further product development is cancelled 
• 
Inability to gather adequate patient data 
 Subject Follow-up for Early Termination or Suspension of Registry 
If the Sponsor suspends or prematurely terminates the clinical investigation 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 CIP and existing agreements.  
 
The investigator will be requested to return all clinical investigation materials to the Sponsor and provide 
a written statement to the IRB/EC (if applicable). All applicable clinical investigation documents shall be 
subject to the same retention policy as detailed in [Section 11.5] of the CIP. 
 
A Principal Investigator, IRB/EC, or regulatory authority may also suspend or prematurely terminate 
participation in the clinical investigation at the investigational site(s) for which they are responsible. The 
investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If a suspended investigation is to be resumed, a prior approval should be obtained from the EC/IRB (if 
applicable) and a notification should be sent to the regulatory bodies (if applicable). 
4.0 
ENDPOINTS  
4.1 
Primary Safety Endpoint and Rationale 
The primary safety endpoint evaluates freedom from LBBAP lead related serious adverse device effects 
(SADEs) through 6 months post-implant attempt. 
 

 
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minimal risk to patients. Safeguards include design of the registry to use only de-identified data and 
reporting pooled results with no direct identification of any individual patient or study center. 
 
It would be impracticable to require individual informed consent from each patient. A requirement of 
informed consent could introduce sampling bias into the findings of the registry since the subset of patients 
who would respond to a solicitation for a chart review and who would provide consent might not be 
representative of the population. 
 
For sites where the governing IRB/EC has not granted a waiver of informed consent, subject will be either 
informed of the nature of the data collection project by means of the privacy notice, or will be asked to 
provide a signed written informed consent, as approved by the IRB/EC. The investigators will be 
responsible to follow the recommended privacy notice or consent rules before starting data collection within 
this registry. 
5.2.2.1 Special Circumstances for Informed Consent  
The following vulnerable populations are excluded from the registry population: 
• 
Individuals under age of 18 or age of legal consent 
5.3 
Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site. Patients must meet ALL 
of the inclusion criteria to be considered for the clinical investigation. If ANY of the exclusion criteria are 
met, the patient is excluded from the clinical investigation and cannot be enrolled (recruitment failure). 
 Inclusion Criteria 
5.3.2.1 Inclusion Criteria 
1) Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left 
Bundle Branch Area on or before January 31, 2023 and subject’s medical records 
contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt 
2) Subject is ≥ 18 years of age or the legal age, whichever age is greater 
3) For sites where the governing IRB/EC has not granted a waiver of informed consent, 
subject has either been informed of the nature of the clinical investigation using a 
privacy notice or has provided a signed written informed consent, as approved by the 
IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing 
IRB/EC or applicable regulation has granted a waiver of patient consent) 
 Exclusion Criteria 
5.3.3.1 Exclusion Criteria 
 
1) Subject was enrolled in another clinical trial during this data collection period that might 
impact the outcomes of the present registry 

 
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5.4 
Subject Enrollment 
Subjects are considered enrolled when research personnel at each participating center verify in the 
health record that all of the inclusion criteria and none of the exclusion criteria are met and, if applicable, 
local required privacy notice or consent rules have been followed. 
5.5 
Subject Withdrawal and Discontinuation 
This is a retrospective data collection registry, so there will be no case of subject withdrawal and 
discontinuation. 
5.6 
Number of Subjects  
Data on a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in 
the registry. 
5.7 
Total Expected Duration of the Clinical Investigation 
The total expected duration of data collection is 
 from activation of the first site. 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS 
As a data collection registry, research personnel at each participating center will collect all of the 
following data from medical records. 
6.1 
Assessment time points 
 Baseline 
The baseline refers to the measurements made within 3 months prior to an attempted implant of the 
TendrilTM STS 2088 lead in the LBBA.  
• 
Demographics (if provided):  sex at birth, age range 
• 
Cardiovascular (CV) history and other significant medical conditions 
• 
Cardiac medications 
• 
Indications for pacemaker or CRT-P/D implant 
• 
Intrinsic QRS duration and QRS morphology (if available) 
• 
NYHA classification (if available) 
• 
LVEF, LVEDV, and LVESV (if available) 
• 
Primary indications for device implant 
 Implant Procedure 
The implant procedure is an attempt implant of the TendrilTM STS 2088 lead in the LBBA. Sites report the 
following measurements from patient’s medical record. 

 
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• 
Procedure and device-related adverse events 
• 
Implant success or failure for an LBBAP lead and if not successful, reasons for unsuccessful 
implant 
• 
Implanted device information 
• 
Number of LBBAP lead repositioning attempts at implant procedure and reason(s) for 
repositioning 
• 
Overall procedure time: skin-to-skin 
• 
Implant procedure time: vascular access to lead fixation 
• 
Fluoroscopy time and radiation dose 
• 
Implant tools used (i.e., catheter, stylet, etc.): manufacturer, model # 
• 
LBBAP capture threshold, pulse width, sense amplitude, and pacing impedance 
• 
12-lead ECGs (if available) 
• 
Post-implantation fluoroscopic images in any views (if available) 
 
LBBAP implantation is considered successful if at least one of the following is met, 
• 
Anatomical confirmation of LBBAP with fluoroscopic images (i.e., spatially oriented LBBAP lead 
implant using RAO or LAO view and contrast injection in RV chamber to confirm deep septal 
implantation for LBBAP) 
• 
Unipolar-paced QRS morphology demonstrated a Qr or qR pattern in lead V1 
• 
Identification of LBB potential on the sensed electrogram 
• 
Demonstration of transition from nonselective to selective LBB/LV septal capture during threshold 
testing 
• 
Stimulation to R-wave peak time in lead V5 or V6 < 90 ms 
 
 Follow-ups 
The post-attempt follow-up visit for LBBAP occurs at 6 months (±3 months), and 12 months (-2, 4 
months, optional), considering standard clinical practice. 
 
• 
LBBAP capture threshold, pulse width, sense amplitude, and pacing impedance 
• 
Adverse event (as applicable) 
• 
Device programming (if available)  
• 
Revision or explant (as applicable)  
• 
Paced QRS duration (if available) 
• 
NYHA classification (if available) 
• 
LVEF, LVEDV, and LVESV (if available) 

 
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6.2 
Schedule of Events 
7.0 
Adverse Events 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
CIP Activity 
Baseline 
(≤ 3 months prior   
to an attempted 
implant of LBBAP, 
required) 
Implant 
Attempt 
(required) 
 
6 Month 
(±3 months 
post-attempt, 
required)* 
12 Month 
(-2, +4 
months post-
attempt, 
optional)* 
Data transfer notification/Informed consent process (if 
required by EC/IRB) 
X 
 
 
 
Demographics (if provided) 
X 
 
 
 
CV history and other significant medical conditions 
X 
 
 
 
Implant indication 
X 
 
 
 
Cardiac Medications  
X 
 
 
 
QRS duration and QRS morphology** (if available) 
X 
X 
X 
X 
NYHA classification (if available) 
X 
 
X 
X 
LVEF, LVEDV, LVESV (if available) 
X 
X 
X 
X 
12-lead ECGs (if available) 
 
X 
 
 
Post-implantation fluoroscopic images in any views (if 
available) 
 
X 
 
 
Implanted device Information 
 
X 
 
 
Number of LBBAP lead repositioning attempts and 
reason(s) for repositioning  
 
X 
 
 
Procedure/fluoroscopy times/radiation dose 
 
X 
 
 
Implant tools information 
 
X 
 
 
LBBAP capture threshold, pulse width, sense 
amplitude, lead impedance  
 
X 
X 
X 
Adverse Event 
 
(X) 
(X) 
(X) 
Death 
(X) 
(X) 
(X) 
(X) 
Product Out of Service 
 
(X) 
(X) 
(X) 
System Revision 
 
(X) 
(X) 
(X) 
(x) if applicable 
* If there are multiple visits within the visit window, the closest visit to 6 and 12 months will be captured using the scheduled follow-up CRF 
and other visit(s) will be captured using the unscheduled follow-up CRF. 
** Intrinsic QRS morphology is only applicable at baseline 

 
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7.1 
Definition 
 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, in the context 
of a clinical investigation, whether or not related to the investigational medical device.  
 
As part of ISO14155 Section 3.2, the Adverse Event definition has the following notes: 
 
Note 1: This definition includes events related to the investigational medical device or the comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices or comparators. 
 Serious Adverse Event 
Serious Adverse Event (SAE) is an AE that led to any of the following:   
 
a) death, 
b) serious deterioration in the health of the subject, that resulted in any of the following:  
1. life-threatening illness or injury,  
2. permanent impairment of a body structure or a body function,  
3. hospitalization or prolongation of patient hospitalization,  
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) fetal distress, fetal death or a congenital physical or mental impairment or birth defect. 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP without a 
serious deterioration in health, is not considered a SAE. 
7.2 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or device under 
investigation caused or contributed to an AE is to be determined by the Investigator and recorded on 
the appropriate CRF form. Determination should be based on the assessment of temporal relationships, 
evidence of alternative etiology, medical/biologic plausibility and patient condition (pre-existing condition). 
7.3 
Adverse Event Reporting 
 Adverse Event Reporting 
General Adverse Event Reporting 

 
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Sites will collect information on all procedure and device-related adverse events, whether serious or 
not, and all death events and report to the Sponsor on an Adverse Event CRF. Sites should update the 
Adverse Event CRF with additional information regarding the event as the information becomes 
available. 
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
Serious Adverse Event Reporting 
The investigator must report all procedure and device-related SAEs to the Sponsor as soon as 
possible.  
 
Sites must record the date the site staff became aware that the event met the criteria of a reportable 
event as per this protocol in the source document. The Investigator will further report the applicable 
events to the local IRB/EC according to the institution’s IRB/EC reporting requirements (if applicable). 
 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report the procedure or device-related SAEs to the country regulatory authority per local 
requirements.  
8.0 
STATISTICAL CONSIDERATIONS 
The following section describes the statistical methods for the clinical investigation. Additional details on 
statistical analyses, including justification of clinical investigation design, sensitivity analyses, poolability 
analyses, subgroup analyses and analysis of descriptive endpoints, will be maintained in a separate 
Statistical Analysis Plan (SAP). 
8.1 
Analysis Populations 
 Enrolled Population 
This analysis population will include enrolled subjects who have been attempted to implant for the 
TendrilTM STS 2088 lead in the LBBA.  
 Successfully Implanted Population 
The successfully implanted population includes enrolled subjects who are successfully implanted with the 
Tendril STS 2088 lead in the left bundle branch area (refer to Section 6.1.2).  
8.2 
Statistical Analyses  
 Primary Safety Endpoint Analysis 
The primary safety endpoint evaluates freedom from LBBAP lead-related SADEs through 6 months post-
implant attempt.  
 
 
 
The hypothesis is formally expressed as:  
 

 
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10.2 Site Principal Investigator Responsibilities 
The role of the Site Principal Investigator is to implement, oversee the management of the day-to-day 
conduct of the clinical investigation as well as ensure data integrity and the rights, safety and well-being 
of the subjects involved in the clinical investigation. The principal investigator shall support monitoring 
and reporting to IRB/EC and local competent authorities as necessary, throughout the conduct of the 
clinical investigation. 
 
The principal investigator is responsible for ensuring adequate training and qualification of the 
investigation site team and for maintaining oversight of their activities. The principal investigator may 
delegate tasks to members of the investigation site team but retains responsibility for the clinical 
investigation. This also applies when activities are outsourced to an external organization by the principal 
investigator in which case he/she shall exercise oversight to ensure the integrity of all tasks performed 
and any data generated by this external organization. 
10.3 Clinical Investigation Finances and Agreements 
Abbott will finance the clinical investigation and will compensate investigational sites for participation in 
the clinical investigation per the conditions of agreement between Abbott and the investigational site. 
10.4 CIP Amendments  
The Sponsor will provide approved CIP amendments to the Investigators prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the IRB/EC or equivalent committee of 
the CIP amendment (administrative changes) or obtaining IRB’s/EC’s approval of the CIP amendment 
(changes in subject care or safety), according to the instructions provided by the Sponsor with the CIP 
amendment.   
 
Sites must document in writing acknowledgement/approval of the CIP amendment by the IRB/EC prior to 
implementation of the CIP amendment. Sites must also provide copies of this documentation to the 
Sponsor. 
10.5 Training 
 Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit, or other appropriate training 
sessions. Over-the-phone or self-training may take place as required. Training of Investigators and 
clinical investigation personnel will include, but is not limited to, the CIP requirements, electronic case 
report form completion, and clinical investigation personnel responsibilities. All Investigators and clinical 
investigation 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 clinical investigation personnel must not 
perform any CIP-related activities that are not considered standard of care at the site.  

 
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10.6 Monitoring  
Sponsor and/or designee will monitor the clinical investigation over its duration according to the CIP-
specific monitoring plan which will include the planned extent of source data verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following criteria 
are met:  
 
• 
The investigator understands and accepts the obligation to conduct the clinical investigation 
according to the CIP and applicable regulations and has signed the Investigator Agreement or the 
Clinical Trial Agreement.  
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the clinical 
investigation and should have access to an adequate number of appropriate subjects to conduct 
the clinical investigation.  
• 
Sites must have source documentation (including original medical records) to substantiate proper 
informed consent procedures (if required), adherence to CIP 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 and will maintain a monitoring visit sign-in 
log 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 investigation-related documents. 
10.7 Deviations from CIP 
The Investigator should not deviate from the CIP for any reason  
 
The Sponsor will not grant any waivers for CIP deviations.  Sites must report all deviations to the 
Sponsor using the Deviation CRF. The Sponsor will monitor the occurrence of CIP for evaluation of 
investigator compliance to the CIP and regulatory requirements and handle according to written 
procedures. Investigators will determine the cause of deviations, implement corrective actions and inform 
their IRB/EC or equivalent committee of CIP deviations in accordance with their specific IRB/EC 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 CIP, or any other conditions of the clinical 
investigation may result in further escalation in accordance with the Sponsor’s written procedures, 

 
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including securing compliance or, at its sole discretion, the Sponsor may terminate the investigator's 
participation in the clinical investigation.  
10.8 Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, including 
source documentation, for inspection during a Quality Assurance audit.  
 
If an investigator is contacted by a Regulatory Agency in relation to this clinical investigation, the 
Investigator will notify 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 clinical investigation (e.g., Form FDA 483, Inspectional Observations, Warning Letters, Inspection 
Reports, etc.). The Sponsor may provide any needed assistance in responding to regulatory audits. 
10.9 Sponsor Auditing 
Sponsor audits may be performed for other clinical investigations as required by the design and/or 
regulatory impact of the investigation.  
1. The Sponsor shall prepare an audit plan as well as the operating procedures for the related duties 
and conduct audits in accordance with the audit plan and the operating procedures. 
2. Individuals engaged in auditing (hereinafter referred to as "auditor") shall be different than those 
in charge of medical device development or monitoring. 
3. The auditor shall prepare an audit report documenting the matters confirmed in the audit to certify 
and verify that the audit has been conducted and submit them to the Sponsor. 
11.0 DATA HANDLING AND RECORD KEEPING  
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the clinical investigation.  
 
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 end of the clinical investigation, 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 investigational sites, if requested.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress records, 
laboratory reports, CRFs, signed ICFs/data collection notifications (if applicable), device accountability 

 
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records (if applicable), correspondence with the IRB/EC and clinical investigation monitor/Sponsor, 
adverse event reports, and information regarding subject completion of the clinical investigation. 
11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions on 
physical access to premises, facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to enter only pseudonymous Personal Information (key-
coded) necessary to conduct the clinical investigation, such as the patient’s medical condition, treatment, 
dates of treatment, etc., into Sponsor’s data management systems. The Sponsor discloses as part of the 
clinical investigation informed consent/data transfer notification process that some Sponsor 
representatives still may see Personal Information at the participating sites for monitoring and quality 
control purposes. All parties will observe confidentiality of Personal Information always throughout the 
clinical investigation. All reports and data publications will preserve the privacy of each subject and 
confidentiality of his/her information. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
11.2 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, issuing 
and resolving data discrepancies, and database locking. If appropriate, the Sponsor may update the 
DMP throughout the duration of the clinical investigation. The Sponsor will track and document control all 
revisions. 
11.3 Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. To comply with these regulatory 
requirements/GCP, sites should include the following information in the subject record at a minimum and 
if applicable to the clinical investigation: 
• 
Medical history/physical condition of the subject before involvement in the clinical investigation 
sufficient to verify CIP entry criteria 

 
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• 
Dated and signed notes on the day of entry into the clinical investigation referencing the Sponsor, 
CIP number, subject ID number, and a statement that informed consent was obtained (if 
applicable) 
• 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
• 
AEs reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including documentation of 
site awareness of SAEs and of investigator assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports and 12-lead ECGs, reviewed and annotated for clinical 
significance of out of range results (if applicable).  
• 
Notes regarding prescription medications taken at baseline 
• 
Subject’s condition upon completion of the clinical investigation 
• 
Any other data required to substantiate data entered into the CRF 
11.4 Case Report Form Completion  
Site research personnel trained on the CIP and CRF completion will perform the primary data collection 
clearly and accurately based on source-documented hospital and/or clinic chart reviews. 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. The Sponsor will use an electronic audit trail 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 clinical 
investigation as per the applicable regulatory record retention requirements. The Investigator must obtain 
permission from Sponsor in writing before destroying or transferring control of any clinical investigation 
records. 
12.0 ETHICAL CONSIDERATION 
 
12.1 Institutional Review Board/Medical Ethics Committee Review and Approval 
The Principal Investigator at each investigational site will obtain IRB/EC approval for the CIP (if 
applicable) and ICF/data transfer notification provided to the patient (if applicable) prior to consenting (if 
applicable) and enrolling patients in this clinical investigation. The site must receive the approval letter 
prior to the start of this clinical investigation and provide a copy to the Sponsor.  
 
Sites will submit any amendments to the CIP as well as associated ICF/data transfer notification changes 
(if applicable) to the IRB/EC and written approval obtained prior to implementation, according to each 
institution’s IRB/EC requirements.  
 

 
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No changes will be made to the CIP or ICF/data transfer notification (if applicable) or other written 
information provided to the patient (if applicable) without appropriate approvals, including IRB/EC, the 
Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her IRB/EC of the progress of 
this clinical investigation, per IRB/EC requirements. Written approval must be obtained from the IRB/EC 
yearly to continue the clinical investigation, or according to each institution’s IRB/EC requirements.  
 
Sites will not perform any investigative procedures, other than those defined in this CIP, on the enrolled 
subjects without the written agreement of the IRB/EC and the Sponsor. 
13.0 CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure. 
 
The Sponsor will submit the clinical investigation report within one year of the end of the investigation to 
the investigational sites, competent authorities and reviewing IRBs and ECs.   
14.0 PUBLICATION POLICY 
The data and results from the clinical investigation are the sole property of the Sponsor. The Sponsor 
shall have the right to access and use all data and results generated during the clinical investigation. The 
Investigators will not use this clinical investigation-related data without the written consent of the Sponsor 
for any purpose other than for clinical investigation 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. The Sponsor must review and approve any proposals for 
publications or presentations by the investigators in a timely manner in compliance with the Sponsor’s 
publication policy set forth in the Clinical Trial Agreement. 
 
The Sponsor will be responsible for registering this clinical investigation on ClinicalTrials.gov website, in 
accordance with the International Committee of Medical Journal Editors guidelines, or any other 
applicable guidelines. Sponsor shall be responsible for any such registration and results posting as 
required by the ClinicalTrials.gov website. Institution and/or Principal Investigator(s) shall not take any 
action to register the clinical investigation. A full report of the pre-specified outcomes, regardless of the 
results, will be made public through the ClinicalTrials.gov website no later than 12 months after clinical 
investigation completion, as required by section 801 of the FDA Amendments Act. If this clinical 
investigation is terminated early, the Sponsor will make every effort to hasten the release of the pre-
specified outcomes through the ClinicalTrials.gov website.  
 

 
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15.0 RISK ANALYSIS 
This is a retrospective data collection registry; no clinical activities will be performed on any subjects. 
Therefore, there is no risk analysis required. 
 
 
 

 
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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Abbreviation 
Term 
AE 
CIP 
DMP 
eCRF 
EDC 
IRB 
LBBAP 
LVEF 
LVEDV 
LVESV 
NA 
RVP 
SADE 
SAE 
Adverse Event 
Clinical Investigational Plan 
Data Management Plan 
Electronic Case Report Form 
Electronic Data Capture 
Institutional Review Board 
Left Bundle Branch Area Pacing 
Left Ventricular Ejection Fraction 
Left Ventricular End Diastolic Volume 
Left Ventricular End Systolic Volume 
Not Applicable 
Right Ventricular Pacing 
Serious Adverse Device Effect 
Serious Adverse Event 
 
 

 
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APPENDIX II: SITE CONTACT INFORMATION 
A list of Clinical Investigational sites will be kept under a separate cover and is available upon request. 
 
 

 
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APPENDIX III: LABELS 
IFU documents will be kept under a separate cover and are available upon request.  
 
 
 

 
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APPENDIX IV: CASE REPORT FORMS 
Case Report Forms will be kept under a separate cover and are available upon request. 
 
 
 

 
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APPENDIX V: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project Manager 
for the clinical investigation. 
 
 

 
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APPENDIX VII: CIP SUMMARY 
Clinical 
Investigation 
Name and 
Number 
LBBAP Data Collection Registry 
Title 
Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry 
Objective(s) 
The LBBAP data collection registry will be conducted to support an indication 
expansion of the TendrilTM STS 2088 lead to include pacing/sensing in the left 
bundle branch area.   
Device Under 
Investigation 
TendrilTM STS 2088 lead 
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation 
Data on a minimum of 220 attempted subjects will be included in order to have 
190 evaluable subjects in this registry. The chart review will be conducted at up 
to 20 centers worldwide. 
Clinical 
Investigation 
Design 
Retrospective, observational, non-randomized, multi-center registry 
 
• 
This registry will retrospectively collect data on LBBAP implants already 
attempted in patients using the Tendril STS 2088 lead. 
• 
Sites should make every effort to enroll consecutive subjects with an 
attempted LBBAP implant  
• 
Sites will retain an enrollment log which links the subject ID and 
identifiable information for traceability purposes in order to address 
inquiries from regulatory agencies, as needed. 
• 
Sites will review patient medical records (i.e., electronic health records) 
and submit only de-identified data through Case Report Forms (CRFs) 
• 
Sites should make all the effort to collect both successful and 
unsuccessful LBBAP implantation attempts for the time being applicable 
to the purpose of this registry by utilizing a device inventory list and/or 
sales data relevant to the usage of the TendrilTM STS 2088 lead. 
• 
Data will be collected from previously occurring visits at baseline 
(required), implant (required), 6 months (± 3 months, required), and 12 
months (-2, +4 months, optional). 
• 
Monitoring by the sponsor will be conducted using a risk-based 
approach to maintain the reliability and data integrity of the data 
included in this registry. 
Waiver of 
Informed Consent 
Waiver of patient informed consent will be requested at each site’s governing 
IRB/EC since this registry involves no more than minimal risk and a requirement 
of individual informed consent would make the conduct of the research 
impracticable1  

 
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• 
No more than minimal risk:  The only risk to patients are related to the 
safeguarding of patient information. The registry design mitigates this 
risk by including controls to ensure there is minimal risk to patients by 
collecting only de-identified data and reporting pooled results with no 
direct identification of any individual patient or study center. 
 
• 
Impracticable to require individual informed consent:  A requirement of 
informed consent could introduce sampling bias into the findings since 
the subset of patients who respond to the solicitation for this registry and 
who provide informed consent may not be representative of the registry 
population 
1Council for International Organizations of Medical S. International ethical guidelines for biomedical research involving 
human subjects. Bull Med Ethics. 2002(182):17-23. 
Primary 
Endpoints 
The primary safety endpoint evaluates freedom from LBBAP lead related serious 
adverse device effects (SADEs) through 6 months post-implant attempt. 
 
The primary effectiveness endpoint evaluates the composite success rate of 
acceptable capture thresholds and sense amplitudes for LBBAP at 6 months 
after successful implantation. 
Subject Follow-up 
• 
Follow-up office visits as noted in subject’s medical records at the following 
scheduled interval: 
Implant (required), 6 months (± 3 months, required), and 12 months (-2, +4 
months, optional) post-implant attempt   
• 
Any visits that occur between this visit schedule will be collected and reported 
as unscheduled visits. 
Inclusion Criteria 
1) Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in 
the Left Bundle Branch Area on or before January 31 2023 and Subject’s 
medical records contain data through at least 6 months (± 3 months) after 
LBBAP implant attempt 
2) Subject is ≥ 18 years of age or the legal age, whichever age is greater 
3) For sites where the governing IRB/EC has not granted a waiver of informed 
consent, subject has either been informed of the nature of the clinical 
investigation using a privacy notice or has provided a signed written 
informed consent, as approved by the IRB/EC (Note: This inclusion criterion 
is not applicable for sites where the governing IRB/EC or applicable 
regulation has granted a waiver of patient consent) 
Exclusion Criteria 
1) Subject was enrolled in another clinical trial during this data collection 
period that might impact the outcomes of the present registry 
 
 
 
 

 
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APPENDIX VIII: REFERENCES 
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Adomian GE and Beazell J. Myofibrillar disarray produced in normal hearts by chronic electrical 
pacing. Am Heart J. 1986;112:79-83. 
2. 
Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA 
and 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. 2003;107:2932-7. 
3. 
Tops LF, Schalij MJ and Bax JJ. The effects of right ventricular apical pacing on ventricular 
function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009;54:764-76. 
4. 
Zhang XH, Chen H, Siu CW, Yiu KH, Chan WS, Lee KL, Chan HW, Lee SW, Fu GS, Lau CP and 
Tse HF. New-onset heart failure after permanent right ventricular apical pacing in patients with acquired 
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5. 
Merchant FM, Hoskins MH, Musat DL, Prillinger JB, Roberts GJ, Nabutovsky Y and Mittal S. 
Incidence and Time Course for Developing Heart Failure With High-Burden Right Ventricular Pacing. 
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Bleeker GB, Schalij MJ, Molhoek SG, Verwey HF, Holman ER, Boersma E, Steendijk P, Van Der 
Wall EE and Bax JJ. Relationship between QRS duration and left ventricular dyssynchrony in patients 
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7. 
Raymond-Paquin A, Padala SK and Ellenbogen KA. Left Bundle Branch Pacing: A Perfect 
Compromise? Arrhythm Electrophysiol Rev. 2021;10:241-243. 
8. 
Padala SK, Cabrera JA and Ellenbogen KA. Anatomy of the cardiac conduction system. Pacing 
Clin Electrophysiol. 2021;44:15-25. 
9. 
Padala SK and Ellenbogen KA. Left bundle branch pacing is the best approach to physiological 
pacing. Heart Rhythm O2. 2020;1:59-67. 
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Padala SK, Master VM, Terricabras M, Chiocchini A, Garg A, Kron J, Shepard R, Kalahasty G, 
Azizi Z, Tsang B, Khaykin Y, Pantano A, Koneru JN, Ellenbogen KA and Verma A. Initial Experience, 
Safety, and Feasibility of Left Bundle Branch Area Pacing: A Multicenter Prospective Study. JACC Clin 
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Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI and 
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Bakelants E and Burri H. Troubleshooting Programming of Conduction System Pacing. Arrhythm 
Electrophysiol Rev. 2021;10:85-90. 
13. 
Ponnusamy SS, Arora V, Namboodiri N, Kumar V, Kapoor A and Vijayaraman P. Left bundle 
branch pacing: A comprehensive review. J Cardiovasc Electrophysiol. 2020;31:2462-2473. 
14. 
Mehta NA, Saqi B, Sabzwari SRA, Gupta R, Vyas A, Gordon J, Cossu S, Nazir T, Freudenberger 
R and Bozorgnia B. Durability of left bundle branch area pacing. J Cardiovasc Electrophysiol. 
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Sharma PS, Patel NR, Ravi V, Zalavadia DV, Dommaraju S, Garg V, Larsen TR, Naperkowski 
AM, Wasserlauf J, Krishnan K, Young W, Pokharel P, Oren JW, Storm RH, Trohman RG, Huang HD, 
Subzposh FA and Vijayaraman P. Clinical outcomes of left bundle branch area pacing compared to right 
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Kiviniemi MS, Pirnes MA, Eranen HJ, Kettunen RV and Hartikainen JE. Complications related to 
permanent pacemaker therapy. Pacing Clin Electrophysiol. 1999;22:711-20. 

 
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17. 
Kistler PM, Liew G and Mond HG. Long-term performance of active-fixation pacing leads: a 
prospective study. Pacing Clin Electrophysiol. 2006;29:226-30. 
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biomedical research involving human subjects. Bull Med Ethics. 2002:17-23.