CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
Conditions: Congestive Heart Failure
Sponsor: Biotronik, Inc.



CELESTIAL
Post Approval Registry
(Corox OTW, Endocardial, Left VEntricular STeroId LeAd, 
BipoLar Post Approval Registry)
November 16, 2010
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, Oregon 97035
This document contains confidential information for use only by investigators 
participating in the post approval registry.  Therefore, this document should be 
maintained in a secure location and should not be copied or made available for 
review by any unauthorized personnel.

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Table of Contents
1.
INTRODUCTION ....................................................................................................................................5
1.1
Name of Device.............................................................................................................................. 5
1.2
Overview and Background .............................................................................................................5
1.2.1
Overview .............................................................................................................................5
1.2.2
Background.........................................................................................................................6
1.2.3
Prior Clinical Experience.....................................................................................................6
1.2.3.1 everesT Study Overview...............................................................................................................6
1.2.3.2 Implant Success Rate Comparison...............................................................................................7
1.2.3.3 Corox BP LV Lead Measurements ...............................................................................................7
1.2.3.4 Freedom from Corox BP LV Lead Related Complications............................................................9
1.3
Device Descriptions......................................................................................................................10
1.3.1
Corox BP LV Leads...........................................................................................................10
1.3.1.1 Corox OTW BP...........................................................................................................................10
1.3.1.2 Corox OTW-S BP .......................................................................................................................10
2.
STUDY DESIGN...................................................................................................................................12
2.1
Study Endpoints ...........................................................................................................................12
2.2
Primary Endpoint 1:  Safety of Corox OTW (-S) LV Leads Pacing – Overall Complication-Free 
Rate
...................................................................................................................................................12
2.3
Primary Endpoint 2: Safety of Corox BP LV Leads – Individual Complication Rates..................14
2.4
Secondary Endpoints ...................................................................................................................14
2.5
Additional Data of Interest ............................................................................................................14
2.6
Registry Size ................................................................................................................................15
2.7
Data Analysis................................................................................................................................16
2.7.1
Trend Analyses .................................................................................................................17
2.7.2
Missing Data .....................................................................................................................18
2.8
Study Organization.......................................................................................................................18
2.8.1
Electronic Data Capture (EDC).........................................................................................18
3.
PROTOCOL REQUIREMENTS ...........................................................................................................19
3.1
Patient Population ........................................................................................................................19
3.1.1
Indications .........................................................................................................................19
3.1.2
Contraindications ..............................................................................................................19
3.1.3
Inclusion Criteria ...............................................................................................................19
3.1.4
Exclusion Criteria ..............................................................................................................20
3.2
Post Approval Registry Design.....................................................................................................20
3.2.1
Procedure..........................................................................................................................20
3.2.2
Study Visits .......................................................................................................................20
3.2.3
Screening Visit ..................................................................................................................21
3.2.4
Enrollment Visit (within 30 days of screening visit)...........................................................21
3.2.5
Routine and Unscheduled Follow-Ups..............................................................................22
4.
STUDY DOCUMENTATION AND DATA COLLECTION....................................................................22
4.1
Electronic Case Report Forms (eCRFs).......................................................................................22
4.2
Data Quality Control .....................................................................................................................23
4.3
Patient Retention..........................................................................................................................23

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5.
PATIENT CONSENT............................................................................................................................24
6.
CONFIDENTIALITY AND RISK ANALYSIS .......................................................................................24
6.1
Patient Data Confidentiality..........................................................................................................24
6.2
Risks and Risk Minimization.........................................................................................................24
7.
MONITORING ......................................................................................................................................24
7.1
Summary ......................................................................................................................................24
7.2
Registry Monitors..........................................................................................................................25
7.3
Monitoring.....................................................................................................................................25
7.4
Registry Completion .....................................................................................................................25
7.5
Deviation from the Investigational Plan........................................................................................26
7.6
Adverse Events ............................................................................................................................26
7.7
Clinical Events Committee ...........................................................................................................28
7.8
Patient Death................................................................................................................................29
7.9
IRB Approval ................................................................................................................................29
7.10 Other Institutions and Physicians.................................................................................................29
8.
RECORDS AND REPORTS ................................................................................................................30
8.1
Investigator Records.....................................................................................................................30
8.2
Investigator Reports .....................................................................................................................30
8.3
Sponsor Records..........................................................................................................................31
8.4
Sponsor Reports...........................................................................................................................32
APPENDIX A: DEFINITION OF TERMS....................................................................................................33
APPENDIX B: TIMELINE ...........................................................................................................................37
Table of Figures
Figure 1: Corox OTW Bipolar LV Leads.................................................................................................. 11
Table of Tables
Table 1: Implant Success Rate Comparison ............................................................................................7
Table 2: Corox BP LV Lead: Pacing Parameters .....................................................................................8
Table 3: Comparison of Freedom from Adverse Events in the Corox BP LV Lead to Other 
Published Study Results ............................................................................................................9
Table 4: Adverse Event Exclusions ........................................................................................................13
Table 5: Primary Safety Endpoints Sample Sizes .................................................................................16

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CELESTIAL POST-APPROVAL REGISTRY
PROTOCOL SIGNATURE PAGE
The signature below constitutes the receipt and review of the CELESTIAL protocol and 
any attachments, and provides the necessary assurances that this registry will be 
conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable 
U.S. federal regulations, ICH and GCP guidelines.
PRINCIPAL INVESTIGATOR:
Signed:
Date:
Name (please print)
Signature
Date:

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PROTOCOL SUMMARY
Title:
CELESTIAL Post-Approval Registry
Design:
This study is a long-term post approval registry designed to follow at least
2500 patients implanted with BIOTRONIK’s Corox BP left ventricular lead.
Each patient will be followed for 5 years.
Purpose:
The purpose of this post-approval registry is to confirm long-term safety and 
successful biventricular pacing for BIOTRONIK’s Corox BP left ventricular (LV)
pacing leads as used in conjunction with any BIOTRONIK CRT pulse 
generator (CRT pacemaker (CRT-P) or CRT defibrillator (CRT-D)). The 
evaluation of safety will be based on the analysis of Corox BP LV lead related 
adverse events. The CELESTIAL post-approval registry will provide data to 
permit characterization of any LV lead failures contributing to patients losing 
CRT. Additionally, acute and chronic LV lead parameters for pacing thresholds 
and impedance will be evaluated.
Patient Population:
Patients who require treatment for advanced heart failure through any CRT-P
or CRT-D. Patient must be successfully implanted with a BIOTRONIK CRT 
system, including a Corox BP LV lead, from 7-180 days prior to enrollment.
Enrollment:
This post approval registry will include a minimum of 2500 patients from up to 
100 centers. The collection of data will continue for five years for each enrolled 
subject.
Clinical Sites:
Up to 100 sites in the United States and internationally.
Primary Endpoints:
The purpose of Primary Endpoint 1 is to evaluate the overall incidence of 
serious adverse events related to the Corox BP LV leads. The purpose of
Primary Endpoint 2 is to evaluate the incidence of each type of serious 
adverse event that contributes to Primary Endpoint 1. 
Secondary Endpoint:
The following secondary endpoints will also be evaluated during the study:
1.
Successful biventricular pacing in a BIOTRONIK CRT device at 
scheduled CELESTIAL registry follow-up visits through 5 years post-
enrollment
2.
Serious adverse event rates for SAEs excluded from primary safety 
endpoint (listed in Table 4) through 5 years post-enrollment.
3.
Pacing threshold, sensing and impedance measurements for the 
Corox BP leads at scheduled CELESTIAL registry follow ups through 5 
years post-enrollment
Sponsor:
BIOTRONIK, Inc.
Clinical Studies Department
6024 SW Jean Road
Lake Oswego, Oregon  97035

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1. INTRODUCTION
1.1 NAME OF DEVICE
This study is a FDA required post approval registry for the BIOTRONIK’s Bipolar Over-
the-Wire (OTW) steroid-eluting left ventricular (LV) pacing leads: Corox OTW Bipolar 
(BP), Corox OTW-S BP, and Corox OTW-L BP, further referred to as Corox BP LV lead 
throughout this protocol. For this study, the Corox BP LV lead is utilized in conjunction 
with any market-released BIOTRONIK Cardiac Resynchronization Therapy (CRT)
device.
1.2 OVERVIEW AND BACKGROUND
1.2.1
Overview
The purpose of this post-approval registry is to confirm long-term safety and reliability of
the Corox BP LV lead as used in conjunction with any BIOTRONIK Cardiac 
Resynchronization Therapy pacemaker or defibrillator (CRT-P or CRT-D).
The 
CELESTIAL post-approval registry will provide data to fully characterize LV lead 
failures, from implant through 5 years, including those failures contributing to patients 
losing CRT therapy. Safety will be evaluated based on the analysis of Corox BP LV lead 
related adverse events, specifically but not limited to conductor fractures and insulation 
failures. Acute and chronic LV lead parameters for sensing, pacing thresholds, and 
impedance will be evaluated from enrollment through 5 years post implant, along with 
analysis of the connector block of the pulse generator at any device change-out. 
Reporting of all Adverse Events will be performed twice a year in order to identify and 
characterize any trend in adverse events, failure modes or failure rates. At least 2500
patients will be enrolled in this post-approval registry, and each patient will be followed 
for five years.
All devices included in the CELESTIAL post approval registry are legally marketed and 
are not investigational products. These devices are being prescribed by physicians 
according to approved FDA indications for use. There is no off-label use of these 
devices in the CELESTIAL post approval registry.
All patients will be screened to ensure they are eligible to participate, and will sign an 
informed consent prior to enrollment into the registry. The informed consent is designed 
to allow the collection of all pertinent LV lead data at implant and up to the time of 
enrollment. During this study, the CRT devices will be programmed to provide cardiac 
resynchronization therapy. Additionally, all patients will continue to receive conventional 
pharmacological therapy for the treatment of CHF and tachyarrhythmias.

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1.2.2
Background
BIOTRONIK developed the Corox BP LV leads for use in biventricular pacing systems.
These leads are polyurethane coated and designed to minimize any system related 
restrictions regarding implantation. Corox BP LV lead can be introduced into the
coronary venous system either by stylet or guidewire. Furthermore, the guidewire can 
be introduced into the lead body from either end (distal or proximal). Sensing and 
pacing through the lead can be programmed in various configurations, allowing optimal 
parameters to be programmed according to each individual patient.
Each of these leads is offered with a different type of fixation. The Corox OTW BP has a
three dimensional pre-shaped helical tip to achieve a stable position in larger veins, 
while Corox OTW-S BP has a tip with a bend at the distal end for stable placement in 
smaller veins (‘wedge position’). Finally, the Corox OTW-L BP has a dual-curve shape 
that is designed to achieve a stable position in larger veins.
The CELESTIAL Post Approval Registry is designed to document the clinical 
experience of the Corox BP LV leads in the United States and internationally as 
required by the FDA through P070008, dated May 12, 2008.
1.2.3
Prior Clinical Experience
1.2.3.1 everesT Study Overview
The 
clinical 
investigation 
everesT: 
“Evaluation 
of 
the 
new 
BIOTRONIK 
Resynchronization+ICD System” evaluated the safety and effectiveness
of the 
Lumax HF-T 300 and 340 CRT-D, as well as the safety and effectiveness of the 
Corox OTW BP and Corox OTW-S BP polyurethane coated LV leads. The Lumax 
devices and Corox BP LV leads are legally marketed in Europe and this multi-center 
study was conducted as a post-market registry to gather sufficient safety and 
effectiveness data for regulatory purposes outside the EU.
While the everesT investigation was designed to study both Lumax devices and Corox 
BP LV leads, only everesT results from the Corox OTW BP and Corox OTW-S BP LV 
leads are presented in this summary.
For the Corox BP LV lead portion of the everesT clinical study, the primary 
effectiveness endpoint was implant success rate of the Corox BP LV leads compared to 
a pre-defined threshold. Additionally, the evaluation of effectiveness was based on an 
equivalence (non-inferiority) comparison between the implant success rate of the Corox 
BP LV leads and rates reported in prior studies for endocardial LV leads. The evaluation 
of safety was based on analysis of the incidence of Corox BP LV lead related adverse 
events, defined as any complications or observations judged by the investigator to be in 
probable relationship with the Corox BP LV lead.

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1.2.3.2 Corox OTW-L BP Pre-Market Evaluation Overview
The Corox OTW-L BP Pre-Market Evaluation (PME) was completed to assess the 
clinical performance of the Corox OTW-L BP lead. The study was performed by 
collecting acute and chronic lead parameters, investigator assessment, and lead related 
observations. Lead data were collected at implant, hospital pre-discharge and 1-month 
follow-up. This pre-market evaluation was conducted as an observational registry 
without pre-defined endpoints or sample size calculations.
1.2.3.3 Implant Success Rate Comparison
Left ventricular lead placement success rates are dependent on several key factors, 
including: lead design, patient coronary vein anatomy, physician expertise, and 
familiarity of placing LV leads.
During the everesT study, Corox OTW BP LV leads were successfully implanted in 
91.5% of patients (97/106), and Corox OTW-S BP LV leads were successfully 
implanted in 89.5% of patients (34/38).
Overall, the Corox OTW BP and Corox OTW-S
BP LV leads were successfully implanted in 91.0% of patients (131/144). During the 
Corox OTW-L BP LV lead PME, 82.6% of patients (71/86) were successfully implanted 
with the lead. Table 1 compares the implant success rates of the Corox BP LV leads to 
other published study results.
Table 1: Implant Success Rate Comparison
LV Lead
N
BIOTRONIK Corox OTW and Corox OTW-S BP LV leads (everesT)
131/144 (91.0%)
BIOTRONIK Corox OTW-L BP LV leads (Corox OTW-L BP PME)
71/86 (82.6%)
BIOTRONIK Corox OTW UP Steroid
121/132 (91.7%)
St. Jude Aescula 1055K (P030035)
125/146 (85.6%)
St. Jude Aescula 1055K (P030054)
155/175 (88.6%)
St. Jude QuickSite 1056K (P030035)
153/162 (94.4%)
Medtronic Attain Models: 2187, 2188, 4189 (P010031)
374/424 (88.2%)
Guidant Easytrak Models: 4510, 4511, 4512, 4513 (P010012)
448/517 (86.7%)
1.2.3.4 Corox BP LV Lead Measurements
At implant and all routine follow-ups during the everesT clinical study and the Corox 
OTW-L PME, investigators were required to use the implanted pulse generator to obtain 
ventricular lead measurements, including pacing thresholds and lead impedance. All 
measurements were made with a pulse width of 0.5 milliseconds. Intra-operative data 
were measured with an external pacing system analyzer or through the pulse generator.

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Table 2 provides a summary of Corox BP LV lead pacing thresholds as well as lead 
impedance measurements obtained during the these 2 studies. The everesT data 
presented in the first two columns represent combined data from both Corox OTW BP 
and Corox OTW-S BP LV leads. The last 2 columns reflect data from the Corox OTW-L
BP LV lead PME.
Table 2: Corox BP LV Lead: Pacing Parameters
Corox BP (everesT)
Pacing Threshold 
(Volts @ 0.50 ms)
Corox BP (everesT)
Lead Impedance
(Ohms)
Corox OTW-L BP
Pacing Threshold
(Volts @ 0.5 ms)
Corox OTW-L BP
Lead Impedance
(Ohms)
Implant
Number of Tests
121
115
31
30
Mean ± SD
1.2 ± 0.9
839 ± 262
1.0 ± 0.7
723 ± 191
Range
0.2 - 4.5
362 -1720
0.3 - 3.6
470 - 1164
Pre-discharge 
Follow-up
Number of Tests
128
121
32
32
Mean ± SD
1.5 ± 1.3
732 ± 219
1.0 ± 0.6
681 ± 216
Range
0.3 - 7.5
305 -1748
0.3 - 2.6
316 - 1273
One-month 
Follow-up
Number of Tests
108
103
28
31
Mean ± SD
1.3 ± 1.2
806 ± 245
1.1 ± 0.7
745 ± 185
Range
0.3 - 7.5
374 -1652
0.3 - 3.2
427 - 1164
Three-month 
Follow-up
Number of Tests
99
94
N/A
N/A
Mean ± SD
1.2 ± 1.1
788 ± 202
N/A
N/A
Range
0.4 - 5.2
346 -1379
N/A
N/A
Six-month 
Follow-ups
Number of Tests
15
15
N/A
N/A
Mean ± SD
0.8 ± 0.6
886 ± 194
N/A
N/A
Range
0.4 - 2.7
646 -1407
N/A
N/A
All lead impedance and pacing threshold values observed in the everesT study and the 
Corox OTW-L BP LV lead PME are clinically acceptable. Low pacing thresholds and
appropriate lead impedance values may allow the physician to program lower outputs 
while maintaining an adequate safety margin, thereby potentially extending the service
life of the pulse generator.

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1.2.3.5 Freedom from Corox BP LV Lead Related Complications 
During the everesT clinical study, the freedom from Corox BP LV lead related 
complications post-implant was studied. The results were compared to a predetermined 
performance criterion and to the results of other similar prospective LV lead clinical 
trials. Patients who terminated the study before completing all follow-up procedures 
were included up to the point of their study exit. During the Corox OTW-L BP LV lead 
PME, adverse events data were collected through at least 4 weeks for each enrolled 
subject, although none were reported.
Freedom from Corox BP LV lead related adverse events compares favorably with 
results from other manufacturers. Table 3 presents freedom from Corox BP LV lead
related adverse events along with other published results.
Table 3: Comparison of Freedom from Adverse Events in the Corox BP LV Lead
to Other Published Study Results
Study
Results
BIOTRONIK Corox OTW BP
97.9% *
2 complications in 
97 pts
BIOTRONIK Corox OTW-S BP
100% *
0 complications in 
34 pts
BIOTRONIK Corox OTW-L BP
100% †
0 complications in 
32 pts
BIOTRONIK Corox OTW UP Steroid (helix)
92.9%
8 complications in 
8 pts.
St. Jude QuickSite 1056K LV lead (P030054)
96.1% *
8 complications in 
6 pts.
St. Jude Aescula 1055K LV lead (P030035)
88.2%
25 complications in 
24 pts.
Medtronic Attain LV lead Models 4189 (P010031)
85.1%
49 complications in 
44 pts.
Guidant Easytrak LV Lead Models 4510, 4511, 4512, 4513 
(P010012)
87.8%
53 complications in 
517 pts.
*Freedom from LV lead related complications at 3 months
† Freedom from LV lead related complications at 1 month

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1.3
DEVICE DESCRIPTIONS
1.3.1
Corox BP LV Leads
The Corox BP LV leads are a guidewire or stylet delivered, transvenous, steroid-eluting 
family of leads for LV pacing and sensing. A standard 0.014 inch guidewire can be 
introduced from either the distal or proximal end into the lead body. This allows 
alternate usage of a stylet or guidewire until the lead is advanced and properly fixated in 
a coronary vein. The leads are equipped with a “true” stylet stop near the tip, which 
allows full straightening of, and maximal load transmission to, the distal end of the lead 
with a stylet. An integrated distal tip seal situated inside the lead body prevents intrusion 
of fluids into the lead lumen during implantation.
The MP35N/Ag lead conductor core is insulated with silicone and externally coated with 
polyurethane up to the beginning of the helix. A steroid / silicone collar behind the tip 
electrode is designed to slowly elute 0.5 mg of dexamethasone acetate (DXA).
A
second steroid / silicone collar is located next to the ring and slowly elutes 0.5 mg of 
dexamethasone acetate (DXA).
The leads are available in two different lengths (77 & 87 cm), which are designated as 
Corox OTW (-S or -L) 75-BP and Corox OTW (-S or -L) 85-BP, respectively; dedicated 
implant tools include several ScoutPro guiding catheters and Galeo guidewires with 
varying designs, as well as commercially available balloon catheters to facilitate 
coronary sinus angiography for visualization of the venous anatomy.
1.3.1.1 Corox OTW BP
This LV lead model has a helically pre-shaped distal end designed to provide atraumatic
fixation within a coronary vessel (Figure 1 left). The tip is electrically active with an area 
of 5.0 mm2 and a diameter of 5.85 F (1.95 mm). The electrically active ring has an area 
of 8.0 mm2 and a diameter of 5.85 F. The tip and ring electrodes are separated by 18 
mm. To improve pacing and sensing, both electrodes are fractally coated with iridium to 
enhance charge transfer between the conductive sections of the lead and the 
electrolyte.
1.3.1.2 Corox OTW-S BP
This LV lead model has a bend in the distal end enhanced with a silicone screw to 
provide atraumatic fixation within a narrow coronary vessel (Figure 1 right). The tip is 
electrically active with an area of 5.0 mm2 and a diameter of 5.85 F (1.95 mm). The 
electrically active ring has an area of 8.0 mm2 and a diameter of 5.85 F. The tip and ring 
electrodes are separated by 18 mm. To improve pacing and sensing, both electrodes 
are fractally coated with iridium to enhance charge transfer between the conductive 
sections of the lead and the electrolyte.
1.3.1.3 Corox OTW-L BP
The Corox OTW-L BP is a subsequent model of the currently marketed Corox OTW BP 
and Corox OTW-S BP leads. The Corox OTW-L BP lead features design elements 
inherited from the predecessor models, such as electrode shape, size and spacing, 

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however, the Corox OTW-L BP has a new passive fixation structure (Figure 1 bottom). 
This structure is a dual-curved pre-shape, covering approximately 5 cm of the distal 
aspect of lead, and is designed to achieve a stable position in larger veins.
Figure 1: Corox BP LV Leads

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2. STUDY DESIGN
The CELESTIAL post-approval registry is a multi-center, prospective, non-randomized, 
5 year data collection registry. The registry is designed to gather long term safety and 
reliability data on BIOTRONIK’s Corox BP LV leads. All patients enrolled into the clinical 
study will have an implanted BIOTRONIK CRT system, including a Corox BP LV lead, 
and will be enrolled from 7-180 days after successful CRT implantation or system 
revision.
Patients will be followed for 5 years post-implant, and are meant to be seen according 
to each institution’s standard of care, but not to exceed a follow up time frame of (1)
every 6 months for CRT pacemakers (CRT-Ps) or (2) every 4 months for CRT 
defibrillators (CRT-Ds). At enrollment, information will be collected regarding patient 
medical history, demographics, and other secondary data or data of interest specifically 
pertaining to the implant and status of the LV lead. At each follow up, a determination 
will be made whether the system is providing appropriate biventricular pacing.
Additionally, the electrical parameters of the left ventricular lead will be collected, and 
any LV lead related adverse event will be documented.
The primary safety endpoints are constructed to capture all LV lead-related serious 
adverse events (SAEs) that require additional invasive intervention to resolve. Individual 
analysis of each serious adverse event (SAE) will be conducted and reported 
throughout the study. The low probability of SAE mandates the registry study size of a 
minimum of 2000 patients. 
A secondary effectiveness endpoint will utilize a responder analysis of the 
success/failure of the CRT generator implanted with the Corox BP LV lead to deliver 
long-term biventricular pacing through 5 years post-implant.
2.1 STUDY ENDPOINTS
This clinical investigation includes the assessments of two primary safety endpoints
related to the Corox BP LV leads, and several secondary endpoints that include an
evaluation of the long-term delivery of biventricular pacing by BIOTRONIK CRT study 
devices.  The hypotheses associated with the primary safety endpoints are presented 
below.
2.2 PRIMARY ENDPOINT 1: SAFETY OF COROX BP LV LEADS PACING –
OVERALL COMPLICATION-FREE RATE
The purpose of primary endpoint 1 is to evaluate the overall incidence of serious 
adverse events that require additional invasive intervention to resolve, related to the 
Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.
Primary safety endpoint 1 is constructed to capture all LV lead-related serious adverse 
events, not limited to fractures and insulation failures, but excluding those well 
documented adverse events that do not reflect a LV lead failure. 

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The following serious adverse events have been collected and reported by each LV 
lead manufacturer in their respective Summary of Safety and Effectiveness Data 
Reports (P050045, P050023, P030035, P010031, P010015, and P010012). While these 
SAEs will not be counted toward primary endpoint, they will be collected and analyzed 
as pre-specified secondary endpoints.  
Table 4: Adverse Event Exclusions
Adverse Event Exclusions
Estimates of rates from 
prior studies
Inability to place LV Lead
10 - 14%
Lead dislodgements up to 180 days post implant 
procedure
1.9 - 9%
High LV pacing threshold, intermittent LV capture, 
no capture of LV lead
3.6 - 5.6%
Diaphragmatic/pectoral stimulation
0.2 - 2.9%
Infection
1.6 - 2.3%
Atrial lead, ICD lead, or generator adverse events 
requiring additional interventions
1.6 - 36.8%
Non LV lead related  hospitalizations
27.4 - 48.9%
Non LV lead related death
6.2 - 18.9%
Implant procedure related complications such as 
CS dissection, CS perforation, pneumothorax, 
arrhythmias, cardiac tamponade, hematoma
1.5 - 13.3%
LV lead related thrombosis
<0.5%
Implant damage to LV lead (e.g. accidental cut to 
lead body during pocket revision, device 
replacement, etc.)
0.2 - 0.9%
Twiddler’s syndrome
0.2%
Assuming that the expected Corox BP LV lead-related serious adverse event rate
(proportion of subjects with at least one SAE), excluding the above, is 7.5% or less, 
then the primary safety endpoint will be evaluated in the following testable hypothesis in 
a noninferiority format.   
Ho: The serious adverse event-free rate (SAEFR) for the Corox BP LV Leads at 5 years 
post-enrollment is inferior to 92.5%
SAEFR +  
92.5%
Ha: The serious adverse event-free rate (SAEFR) for the Corox BP LV Leads at 5 year 
post-enrollment is not inferior to 92.5%
SAEFR +  
> 92.5%

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Where, ( ) is the clinically significant difference for establishing noninferiority.  A 
rejection of the null hypothesis would indicate that the serious adverse event-free rate is 
not inferior to 92.5% within ( ).
2.3 PRIMARY ENDPOINT 2: SAFETY OF COROX BP LV LEADS – INDIVIDUAL 
COMPLICATION RATES
Each of the individual types of serious adverse events contributing to primary safety 
endpoint 1 will be evaluated separately in the following superiority hypotheses:
Ho: The individual serious adverse event rate (SAEIndividual) for a given type of SAE 
for the Corox BP LV Leads at 5 years post-enrollment is equal to 1%
SAEIndividual =  1%
Ha: The individual serious adverse event rate (SAEIndividual) for a given type of SAE 
for the Corox BP LV Leads at 5 years post-enrollment is not equal to 1%
If the two-sided, 95% upper confidence bound is no more than 1% for individual serious 
adverse events, then the null hypothesis will be rejected for that SAE type.
2.4 SECONDARY ENDPOINTS
1. Successful biventricular pacing in a BIOTRONIK CRT device at scheduled 
CELESTIAL registry follow-up visits through 5 years post-enrollment
2. Serious adverse event rates for SAEs excluded from primary safety endpoint 
(listed in Table 4) through 5 years post-enrollment.
3. Pacing threshold, sensing and impedance measurements for the Corox BP leads 
at scheduled CELESTIAL registry through 5 years post-enrollment
4. Individual electrical parameters of the Corox OTW BP LV lead, the Corox OTW-S
BP LV lead, and the Corox OTW-L BP LV lead.
5. Overall incidence of serious adverse events that meet the primary endpoint 1 
criteria will be evaluated separately for each Corox BP lead model. 
6. Incidence of individual types of serious adverse events contributing to primary 
endpoint 2 will be evaluated separately for each Corox BP lead model.
2.5 ADDITIONAL DATA OF INTEREST
In addition to the data collected in order to support the pre-defined endpoints, the 
CELESTIAL post approval registry will also collect other data of interest:
1. Patient implant data (collected retrospectively from medical chart review)
2. Demographic information
3. All cause adverse events
4. BIOTRONIK RA and RV/ICD lead electrical performances
5. Returned product analyses

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6. Extraction experience
7. Comparison of data collected between Home Monitoring and in-office device 
interrogations
2.6 REGISTRY SIZE
The estimated sample size requirement is based on both primary safety endpoints: a
noninferiority comparison of the overall SAE free-rate to 92.5% at 5 years, excluding 
those SAEs listed in Table 4, and a non-powered, superiority comparison for those 
individual lead-related SAE to 1% at 5 years.  The sample size for primary safety 
endpoint 1 was calculated based on the following assumptions:  
Assumptions for primary safety endpoint 1
Study Design:  nonrandomized registry
Type I error (alpha):  0.05 (one-sided for noninferiority)
Statistical power:  80%
Noninferiority delta:  5%
Estimated SAE-Free Rate at 5 years: 92.5% for Corox BP LV Leads
For primary safety endpoint 1, a total of 240 evaluable subjects implanted with Corox 
BP LV leads would be required to demonstrate the noninferiority within 5% of a SAE 
free-rate of 92.5%.   Assuming a 50% loss to follow-up rate over 5 years of follow-up, a 
total of 480 (240/0.5) subjects would be required to evaluate primary safety endpoint 1.
Enrollment will seek to achieve 240 evaluable subjects for each of the Corox BP LV 
leads.
Assumptions for primary safety endpoint 2
Estimated individual SAE rate at 5 years:  0.4%
Allowable two-sided, upper 95% confidence bound:  1%
For primary safety endpoint 2, a total of 1000 subjects would be required to 
demonstrate a two-sided, upper 95% confidence bound of 1%, assuming an expected 
individual SAE rate of 0.4% (no more than 4 patients with an SAE out of 1000).  
Assuming a 50% loss to follow-up rate over 5 years (10% per year), a total of 2000
(1000/0.5) enrolled patients would be required for evaluation of primary safety endpoint
2.
The required sample sizes for the two primary safety endpoints are summarized in 
Table 5.

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Table 5: Primary Safety Endpoints Sample Sizes
Primary 
Safety 
Endpoint 1:
Overall SAE 
free-rate
Primary
Safety
Endpoint 2:
Individual 
SAE rates
Sample Size of Evaluable Patients
240
1000
Total with 50% Loss to Follow-Up 
over 5 years
480
2000
Due to the addition of the Corox OTW-L BP in the study, the total sample size was 
increased to 2500 to allow for sufficient enrollment of patients with this lead.
Study attrition
For the sample size calculation, a maximum loss to follow-up of 10% per year (50% 
over 5 years) was assumed. The loss to follow-up rate encompasses all causes for 
subjects to be exited from the study, including subject death, device explants, patient 
directed withdrawals, physician directed withdrawals, and loss of contact with the 
subject. BIOTRONIK will make every effort to limit the loss to follow-up, for reasons 
other than subject death and device explants unrelated to device design or 
performance, to less than 20% of the total registry enrollment cohort.
Minimum cohort size
The pre-specified secondary analysis will be conducted as an ad hoc analysis, meaning 
no testable hypothesis is being stated.  Therefore, the minimal cohort size to analyze 
each lead model is based on an assumption of an equal 1/3 distribution of each lead 
model being enrolled in the CELESTIAL Registry.  For the evaluation of the Corox 
OTW-L BP lead, a minimum of 600 evaluable subjects will be necessary.
2.7 DATA ANALYSIS
For both primary safety endpoints 1 and 2, pooling of data from the Corox OTW BP, 
Corox OTW-S BP, and Corox OTW-L BP LV leads will be justified as part of the final 
data analysis. The differences in outcomes for the Corox OTW BP, Corox OTW-S BP, 
and Corox OTW-L BP LV leads will be tested using an exact, Chi-square test. If no 
evidence is found of differences between the Corox OTW BP, Corox OTW-S BP, and 
Corox OTW-L BP LV leads (p > 0.05), then the results will be considered poolable for 
purposes of testing the protocol hypotheses associated with the two primary endpoints. 
If evidence of differences is found for a given endpoint, then the hypotheses for that 
endpoint will additionally be tested separately for each LV lead. 

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Primary safety endpoint 1 will be evaluated by performing an exact, noninferiority test 
comparing a binomial proportion (overall SAE free-rate at 5 years) to 92.5%, with a 
noninferiority delta of 5%. Equivalently, the upper, one-sided 95% confidence bound for 
the absolute difference between the overall SAE free-rate and 92.5% must not exceed 
5%.
The evaluation of primary safety endpoint 2 will be based on the exact, two-sided 95% 
confidence interval for the observed, individual SAE rates at 5 years.  The upper bound 
of these 95% confidence intervals must be less than 1%.
The secondary endpoint of successful biventricular pacing will be summarized as a 
success rate at each of the scheduled CELESTIAL follow-up visits through 5 years post-
enrollment, together with the associated exact, 95% confidence intervals.
The secondary endpoint of other SAEs at 5 years, which were excluded from the 
primary safety analyses (listed in Table 5), will also be summarized as SAE rates  
together with their associated exact, 95% confidence intervals. 
The secondary endpoints of pacing threshold and impedance measurements for the 
Corox BP LV leads will be summarized at scheduled visits where they were evaluated, 
using standard measures, including means, standard deviations, medians, minimums, 
and maximums.
The secondary endpoint for overall incidence of serious adverse events that meet the 
primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model 
using the criteria established for primary safety endpoint 1 and 2.
2.7.1 Trend Analyses
The primary safety endpoints are evaluated at 5 years post-enrollment against pre-
specified performance levels (92.5% for overall freedom from Corox BP LV lead-rated 
SAEs, 1% for individual SAE rates). To monitor the ongoing incidence of any potential 
SAEs against the accumulating follow-up exposure post-enrollment, Kaplan-Meier 
actuarial survivor curves will be prepared at the reporting intervals for these safety 
outcomes. Root causes for any failures, regardless of the incidence rates, will be 
investigated.  
If the observed cumulative survival rates fall below the 5-year target values (92.5% of 
overall freedom from SAEs, 99% for individual SAEs) at any time during the study, or 
are projected to fall below the target values, then BIOTRONIK will summarize the 
observed data and the results of its failure investigations, and report the findings to the 
FDA at or before the next scheduled status report.  If at any time a single unanticipated 
serious adverse event or device failure, or combination of events, is believed to have 
implications regarding the safety of current or future patients, then this will be reported 
immediately to the FDA.

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2.7.2 Missing Data
The reasons for any missing data in the study will be documented.  The sponsor will 
examine both missing-data patterns, which describe which values are observed and 
which are missing, and the missing-data mechanisms, which concern the relationship 
between missingness and the values of variables in the study data set [R.J.A. Little and 
D.B. Rubin, 2002, Statistical Analysis with Missing Data, 2nd edition, Wiley and Sons].
For evaluation of the primary study endpoints (safety endpoints 1 and 2), only patients 
who achieve 5 years of follow-up or have experienced a serious adverse event prior to 5 
years will be included in the evaluation of the associated hypotheses.   The secondary 
endpoint of other SAEs at 5 years, excluded from the primary safety analyses, will be 
analyzed in similar manner.  There will be no imputation for these missing adverse 
event outcomes.
For purposes of Kaplan-Meier actuarial analyses, described in Section 2.7.1 Trend 
Analyses, all SAE data on enrolled patients will be included, with follow-up time 
censored at the time of withdrawal or last completed follow-up visit.
Secondary endpoints, which include successful biventricular pacing, pacing thresholds, 
sensing and impedance measurements will be analyzed in two ways.  Initially, all 
available results will be summarized by scheduled visit through the 5 years of study 
follow-up. Afterwards, a last value carried forward (LVCF) will be used to estimate the 
values at the final 5-year follow-up evaluation.
2.8 STUDY ORGANIZATION
2.8.1 Electronic Data Capture (EDC)
MedNet Solutions Incorporated is a privately-held company that specializes in Web-
based clinical database and data management technology. MedNet’s responsibility is to 
partner with BIOTRONIK in the development, implementation, and on-going support of 
a system for an eClinical Solution including EDC of clinical trial data for the CELESTIAL
post-approval registry. MedNet will configure a web-based eClinical system to meet the 
specific goals and needs of BIOTRONIK for the CELESTIAL registry. MedNet will host 
the Oracle database utilized for the EDC system. This system is 21 CFR Part 11 
compliant and will be the conduit for the electronic case report form (eCRF) data entry, 
data validation, and access to real-time configured functions, tools, and reports for 
BIOTRONIK, specified investigational sites, and any other parties authorized by 
BIOTRONIK.

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3. PROTOCOL REQUIREMENTS
3.1 PATIENT POPULATION
This post approval registry will include a minimum of 2500 patients from up to 100
centers. The collection of data will continue for five years for each enrolled subject.
The investigator is responsible for screening all potential patients and selecting those 
who are appropriate for registry inclusion. The patients selected for participation should 
be from the investigator's general patient population according to the inclusion and 
exclusion criteria described below. Patients declining participation will be documented 
on a screen failure log describing the primary reason.
3.1.1
Indications
Corox BP LV Lead
The Corox OTW BP, Corox OTW-S BP, and Corox OTW-L BP left ventricular pacing 
leads are bipolar steroid-eluting leads, intended for permanent implantation in the left 
ventricle via the coronary veins to provide pacing and/or sensing when used in 
conjunction with a compatible IS-1 pulse generator.  
In this post-approval registry, any legally-marketed BIOTRONIK CRT device may be
used (e.g. CRT-D: Lumax HF-T and any future CRT-D; CRT-P: Stratos LV and any 
future CRT-P).
3.1.2
Contraindications
Corox BP LV Lead
The use of the Corox BP LV leads is contraindicated under the following circumstances:
Coronary sinus anomalies
Tissue in the coronary sinus area that has been damaged by an infarction
Any anomalies of the venous system that preclude transvenous implantation of 
the lead
Patient cannot tolerate a single systemic dose of up to 1.0 mg of dexamethasone 
acetate (DXA)
3.1.3
Inclusion Criteria
To support the objectives of this post-approval registry, patients are required to meet 
the following inclusion criteria prior to enrollment:
Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead,
from 7-180 days prior to enrollment.
Able to understand the nature of the registry and give informed consent 

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Available for follow-up visits on a regular basis at the investigational site
Age greater than or equal to 18 years
3.1.4
Exclusion Criteria
To support the objectives of this registry, the exclusion criteria at the time of patient 
enrollment include:
Enrolled in any IDE clinical study
Planned cardiac surgical procedures or interventional measures within the next 6
months
Expected to receive a heart transplant within 1 year
Life expectancy less than 1 year
Presence of another life-threatening, underlying illness separate from their 
cardiac disorder
Pregnancy
Inability to provide date of implant, devices implanted, age, gender, and whether 
the patient experienced any protocol-defined adverse events since implant
3.2
POST APPROVAL REGISTRY DESIGN
3.2.1
Procedure
This is a prospective registry involving a minimum of 2500 subjects from up to 100
centers. Subjects will be enrolled 7-180 days after successful implantation of a
BIOTRONIK CRT device utilizing a Corox BP LV lead. At enrollment, each registry 
patient should
have CRT programmed “ON”.
Additionally, BIOTRONIK Home 
Monitoring should be activated in all subjects. Standard Home Monitoring reports will be 
available to investigators.  Home monitoring data can be utilized to assist in triage and 
diagnosis of LV lead-related adverse events.
3.2.2
Study Visits
The specific visits that are part of this registry are provided in the following bullets, and
the procedures are described in more detail in the following sections:
Screening Visit
Enrollment
Routine and unscheduled follow-ups through 5 years post-implant (every 
subsequent follow up that is scheduled according to each institution’s 
standard of care)

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3.2.3
Screening Visit
Prior to enrollment, the patient’s background and history must be reviewed in order to 
ensure they are an appropriate candidate for the registry. In addition, all patients must 
satisfy the inclusion and exclusion criteria prior to enrollment, including having an 
implanted BIOTRONIK CRT system utilizing a Corox BP LV lead.  After the patient has 
passed this screening process, informed consent must be obtained from the patient 
prior to initiating any registry-related procedures.
The following are required at this visit:
Ensure registry candidacy by answering inclusion and exclusion criteria
Administer Informed consent
3.2.4
Enrollment Visit (within 30 days of screening visit)
After Informed Consent has been obtained and the patient has been determined to be 
eligible for the registry, data is collected in the Enrollment Visit. Typically the Screening 
Visit and the Enrollment Visit happen concurrently.
The following are required at the Enrollment Visit:
Collect retrospective implant information from medical chart review
Date of implant
Implant approach/method, and venous access
Implant location of pulse generator and implanted leads
Implant procedure durations, if available
Collect patient demographics (gender, height, weight, etc.)
Medical history of patient
Bradycardia or ICD indication with Heart Failure
NYHA classification
LVEF %, if available; date and method obtained
Collect information on implanted system (pulse generator and leads 
manufacturer/model, serial numbers, etc.)
Record electrical parameters of the implanted leads
Record any cardiac related adverse event between implant and the 
enrollment visit
Programming parameters should be set to best suit the needs of the patient. If adequate 
system function, including effective CRT, cannot be obtained, the patient should not be 
enrolled in this registry.

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3.2.5
Routine and Unscheduled Follow-Ups
Patients enrolled in the CELESTIAL post approval registry can be implanted with either 
a CRT Pacemaker (CRT-P) or a CRT Defibrillator (CRT-D). Follow-up schedules for 
these devices vary by practice, but typically occur every 3-4 months for a CRT-D and 
every 6 months for a CRT-P. Therefore patients will be seen for routine follow-up visits 
per their institutional standard of care, but not to exceed every 6 months. All scheduled 
follow up windows are ± 1 month.
Any time a patient is seen outside of a required follow-up window according to each 
site’s pre-determined specific follow-up scheduling practice, that visit is considered an 
unscheduled follow-up. Each site Principal Investigator (PI) and Clinical Research 
Coordinator (CRC) will be trained to identify and schedule follow-ups to meet this 
expectation. Additionally, the EDC will provide assistance in identifying properly 
scheduled follow-ups according to this protocol by assisting in the selection of the 
proper electronic Case Report Form (eCRF).
The following are required at each follow-up visit:
Interrogate programmed parameters
Determine lead electrical parameters
Evaluate device diagnostics and programmed parameters to ensure CRT is 
programmed “ON” and the device is correctly providing CRT therapy
Record % of CRT pacing
Determine if there are any cardiac-related Adverse Events. If there are, 
complete the Adverse Event eCRF
Complete all appropriate eCRF’s
4. STUDY DOCUMENTATION AND DATA COLLECTION
4.1 ELECTRONIC CASE REPORT FORMS (ECRFS)
Original data will be collected from each investigational site and recorded into a secure 
Electronic Data Capture (EDC) application hosted by MedNet Solutions, Minneapolis, 
Minnesota, and audited and monitored by BIOTRONIK. 
Information from electronically delivered source data (e.g. programmers) will be 
captured and stored in a validated environment until the end of the study.
The investigator will be required to use his/her electronic signature to verify the content 
of the data reported in the eCRFs.
Patient follow-up is required for all subjects enrolled in this clinical registry. The follow-
up visit date is based on the Corox BP LV lead implant date, and are to be used for:

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Screening Visit
Enrollment (7-180 days after Corox BP LV lead implant or lead revision)
Medical History and Implant (at enrollment)
Routine follow-ups (every 3-4 months for a CRT-D and every 6 months for a 
CRT-P, ± 1 month)
Unscheduled cardiac related physician or hospital visits
Final 5 Year follow-up (± 1 month)
All cause Adverse Events
Study Exit
Patient Non-Compliance
4.2 DATA QUALITY CONTROL
BIOTRONIK will monitor study data closely. At any time, reports can be generated on 
data completion and missing data by the sponsor and by approved research personnel 
at each investigational site. An EDC system will be used to track received and expected 
follow-up data and eCRFs for each participant. This system provides the capability to 
monitor the status, volume, and disposition of data as well as to identify data completed, 
due, overdue, and backlogged. In addition, all study data will undergo extensive 
automatic edit and plausibility checks which provide information to the investigational 
sites to help improve and maintain data quality control procedures designed to detect 
inaccuracies and inconsistencies. 
4.3 PATIENT RETENTION
Although the CELESTIAL Study sample size has been calculated with a 10% patient 
attrition rate per year (50% in 5 years), patient retention in a 5 year study may pose 
additional, unforeseen challenges. Therefore, BIOTRONIK has provided additional tools 
in an effort to minimize the number of patients that are lost to follow-up.  The EDC 
system includes an overview of each patient’s follow-up schedule, including the 
tolerance windows for each follow-up. The EDC system also provides a patient follow-
up scheduling tool in the form of a Visit Scheduler Report. This report allows research 
personnel to become alerted to and track all study patients that should be scheduled for 
upcoming follow-ups. Additionally, the EDC system will automatically provide a bi-
weekly action item list to each site coordinator in the form of email, which includes all 
patients that are due for scheduling.
Finally, to ensure protocol and follow-up compliance at all participating investigational 
sites, BIOTRONIK monitors will conduct monitoring visits (see Section 7).
Monitoring 
visits include a review of patients that may be lost to follow-up.

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5. PATIENT CONSENT
Patient participation in this registry is voluntary. It is required that all patients sign an 
IRB approved Patient Information and Consent Form (ICF) prior to participation in the 
registry. Patient informed consent must be obtained before enrollment and any protocol 
related procedures. To assist with the consent process, BIOTRONIK will provide a
template patient ICF to participating sites.
The investigator is required to inform the sponsor and the reviewing IRB within 5 days if 
any patient was not appropriately consented to participate in the registry. The sponsor is 
then required to report any failure to obtain patient consent to the FDA within 5 working 
days of learning of such an event. 
6. CONFIDENTIALITY AND RISK ANALYSIS
6.1 PATIENT DATA CONFIDENTIALITY
All information sent to BIOTRONIK pertaining to each patient will be kept confidential at 
BIOTRONIK and is subject to FDA audit. Reports submitted to the physician or 
publications of registry results will not make any reference to patient names.
In order to verify the study data and ensure study integrity, monitors from BIOTRONIK, 
the FDA, and the reviewing Investigational Review Board (IRB) may review and/or copy 
the study records.
6.2 RISKS AND RISK MINIMIZATION
This is a post-approval registry conducted using legally marketed devices implanted 
according to their approved labeling. BIOTRONIK foresees no additional risks 
associated with this registry beyond those stated in the labeling for the respective pulse 
generators and leads.
7. MONITORING
7.1 SUMMARY
BIOTRONIK, Inc. is the "sponsor" of the clinical registry. A sponsor is defined as an 
entity that initiates but does not conduct a post-approval registry. BIOTRONIK’s
responsibility as the post-approval registry sponsor is to ensure protocol and regulatory 
compliance through periodic
monitoring of the investigation. BIOTRONIK
has 
determined that this clinical investigation is not a significant risk study, as it concerns 
only legally marketed devices that are used in accordance with approved labeling. 
However, BIOTRONIK requires IRB review and a Patient Information and Consent form 
for all after-market research.

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7.2 REGISTRY MONITORS
Registry monitors are trained, qualified, and designated by BIOTRONIK management to 
oversee the progress of a registry at the clinical site. The address for submitting clinical 
data to BIOTRONIK for this registry is:
BIOTRONIK, Inc.
Attn: CELESTIAL Registry
Clinical Studies Department
6024 Jean Road
Lake Oswego, Oregon 97035
Clinical data may also be submitted by fax to:
(800) 723-9220
For technical assistance 24 hours a day, call:
(800) 284-6689
7.3 MONITORING
A monitor may visit the post-approval registry site periodically throughout the registry.
The sponsor may also require the presence of personnel from BIOTRONIK at follow-up
procedures outlined by this protocol in order to assist the investigator and other site 
personnel. During periodic monitoring visits, assessment of the study site will include 
the following:
Completion and submission of the required eCRFs and other applicable 
registry documentation
Continued acceptability of the facilities
Adherence to the clinical protocol
Adherence to the applicable FDA regulations regarding the obligations of the 
investigator and maintenance of records
7.4 REGISTRY COMPLETION
BIOTRONIK will notify the post-approval registry site upon completion or termination of 
the registry or of the investigator’s participation. At the sponsor’s request, an 
investigator will return any equipment and pertinent information in their possession. The 
sponsor will provide a final report to each investigational site as required by FDA 
regulations. After FDA has agreed to terminate this registry, BIOTRONIK personnel will 
conduct a registry closure visit. During this final visit, BIOTRONIK will verify records and 
ensure that the investigator understands any applicable regulatory requirements,
including those related to record retention. The investigator must retain records related 
to the registry for a period of 2 years after the investigation is completed.

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7.5 DEVIATION FROM THE INVESTIGATIONAL PLAN
The investigator is required to conduct this registry in accordance with the signed
investigator agreement and clinical protocol. The investigator shall notify the sponsor 
and reviewing IRB in writing no later than 5 working days after any significant deviation 
from the post approval registry that has occurred to protect the life or physical well being 
of a subject in an emergency. Except in such emergency, prior approval by the sponsor 
is required for significant deviations from the post-approval registry.
BIOTRONIK categorizes protocol non-compliance instances as either violations or
deviations. Both protocol violations and deviations will be reported to FDA in the form of 
progress reports as necessary.
Protocol violations are defined as instances where the protocol requirements and/or 
regulatory guidelines were not followed, and are generally more serious in nature. 
Protocol violations are considered to potentially affect the scientific soundness of the 
study and/or the rights, safety, or welfare of subjects. Protocol violations include, but are 
not limited to, failure to obtain consent and patient inclusion/exclusion violations. These 
violations will be reported to FDA in accordance with applicable regulatory timelines,
and the site must notify the reviewing IRB. Protocol violations must also be reported to 
the sponsor via Case Report Forms.
Protocol deviations are deviations from the requirements of the protocol in such a 
manner whereby data may not be usable or is not available. Protocol deviations are less 
serious in nature and do not require IRB notification as long as they do not effect the 
rights, safety, or welfare of the registry patient. Protocol deviations from the post-
approval registry must be reported to the sponsor via Electronic Data Capture.
7.6 ADVERSE EVENTS
The investigator will be required to assess the association of each reported adverse 
event to the implant procedure, implanted system including the generator, any lead, or 
the Corox BP LV lead. For each of these relationships, the investigators will indicate 
whether the Adverse Event is not related, related, possibly related, or unknown. 
All Adverse Events will be adjudicated by the Clinical Events Committee (see Section 
7.7 Clinical Events Committee). The Clinical Events Committee (CEC) will have the 
responsibility to adjudicate all Adverse Events into one of the following three final 
classifications: related, not related, or unknown.

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In evaluation of the two primary safety endpoints, the estimates of SAE rates will be 
based on the number of patients with at least one related SAE as a proportion of total 
patients with no SAEs, related SAEs, or unrelated SAEs. Patients with a final 
adjudicated relatedness SAE classification of unknown will not have that individual 
unknown event contribute to or be included in the evaluation of primary safety endpoint 
1 (overall complication-free rate). Patients with an adjudicated relatedness SAE 
classification of unknown for a specific type of individual SAE will not have that 
individual unknown event contribute to or be included in the evaluation of that type of 
SAE in primary safety endpoint 2. However, for purposes of Kaplan-Meier actuarial 
analyses, described in Section 2.7.1 Trend Analyses and Section 2.7.2 Missing Data, all
SAE data on enrolled patients will be included, with follow-up time censored at the time 
of withdrawal or last completed follow-up visit.
For the purposes of this registry, an adverse event is considered to be implant related if 
any one of the following occurred:
Coronary sinus dissection
Coronary sinus perforation
Pneumothorax
Arrhythmias
Cardiac Perforation with or without tamponade
Non-healing pocket dehiscence requiring intervention
Hematoma 
Other event requiring surgical intervention
Additionally, for purposes of this registry, an adverse event is considered to have 
occurred at any point if both of the following conditions are met:
Condition One (definitions can be found in Appendix A: Definition of Terms)
Infection
Cardiac perforation with or without tamponade
Lead dislodgment
High pacing threshold, intermittent capture, no lead capture
Diaphragmatic/pectoral stimulation
Lead impedance out of range, high impedance
Lead impedance out of range, low impedance
Lead related thrombosis
Implant damage to lead (e.g. accidental cut to lead body during pocket revision, 
device replacement, etc.)
Premature battery depletion
Suspected lead failure
Suspected generator failure
Twiddler’s Syndrome
Lead undersensing or loss of sensing
Skin erosion

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Condition Two:
Lead pacing polarity or pacing mode reprogrammed due to suspected lead 
failure
Lead surgically repositioned
Lead surgically explanted
Lead surgically replaced
Lead surgically abandoned
Lead abandoned and pacing disabled
Lead use continued based on medical judgment despite a known clinical 
performance issue
Other lead related surgery performed 
Note: If Condition One is corrected by reprogramming the pulse generator or lead (other 
than changing the polarity or pacing mode) and no other invasive action was taken, then 
the event will not be considered an adverse event and should not be reported. Similarly,
programming changes in pacing polarity/vector or pacing mode that are not due to a 
suspected lead failure will likewise not be considered an adverse event and should not 
be reported. For example, electrical reprogramming of the pacing polarity to eliminate 
diaphragmatic stimulation will not be considered an adverse event.
The adverse events that the IRB considers reportable are dependent on the particular 
IRB.  The protocol-defined Adverse Events not related to the Corox BP LV lead are 
detailed in Table 4. To avoid underreporting, BIOTRONIK recommends that, at a 
minimum, the investigational site reports the adverse events detailed above that occur 
during the CELESTIAL post approval study to BIOTRONIK and their IRB.
The investigational site should report the Adverse Event on the Adverse Event eCRF.
Additionally, registry sites may report adverse events through MedWatch, FDA’s 
adverse event reporting tool for market-released devices. As defined in BIOTRONIK’s 
internal procedures, these adverse events may be reported by BIOTRONIK through 
manufacturer’s MedWatch reports.
7.7 CLINICAL EVENTS COMMITTEE
A Clinical Events Committee (CEC) consisting of at least 3 independent 
Electrophysiologists will be established to review and adjudicate all adverse events that 
occur during the study according to the protocol definitions. The CEC will be blinded to 
the investigational site and the patient identity.  The CEC members will not participate 
as investigators, in order to minimize any potential bias.
The CEC will create a study specific charter defining the adverse event adjudication 
process, specifically detailing review guidelines along with appropriate response 
timelines.

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7.8
PATIENT DEATH
Personnel at the investigational site should notify BIOTRONIK as soon as possible 
concerning any patient death during the investigation. This notification should include a 
completed Study Exit eCRF and copy of the notification of death (death report) sent to 
the IRB. The death report should include all of the following, if available:
date and time of death
place of death
identification of the rhythm at the time of death, if known (include any 
available documentation)
immediate cause of death
any other circumstances surrounding the death
whether the death was device related
Any implanted legally marketed devices that are explanted, including the Corox BP LV 
lead should be returned to BIOTRONIK for analysis.
7.9
IRB APPROVAL
Institutional Review Board (IRB) approval is required from each site prior to participation 
in this clinical registry. Patient enrollment may not begin until the IRB and BIOTRONIK
have granted approval for the registry site. IRB approval is also required throughout the 
duration of this clinical investigation. If IRB approval is withdrawn for a site, BIOTRONIK
must be notified within 5 working days. 
7.10 OTHER INSTITUTIONS AND PHYSICIANS
This investigational registry is not transferable to other institutions attended by the 
investigator unless prior approval is obtained from both BIOTRONIK and the 
appropriate IRB. Only approved investigators are authorized to participate in the 
registry. However, there are certain situations where an investigator might not be 
immediately available to provide the necessary medical care for a patient with a registry
device (e.g. when a patient goes to the emergency room for medical treatment). In any 
such situations, the IRB and investigator must continue to provide oversight for that 
patient’s medical care and rights as a research subject. BIOTRONIK will ensure that the 
necessary support personnel are available to any physician providing immediate care 
for a patient in order to answer questions about the device and provide guidance in 
collecting the necessary documentation required for the post-approval
registry.
Documentation obtained will then be forwarded to the approved investigator for review 
and signature.

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8. RECORDS AND REPORTS
8.1 INVESTIGATOR RECORDS
The physician is required to maintain the following accurate, complete, and current 
records pertaining to this post-approval registry:
All correspondence relating to the registry: e.g. with another investigator, IRB, the 
sponsor, a monitor, or the FDA
Records of each patient, including case history, data forms, patient consent, and 
supporting documentation
A copy of the registry protocol
Signed investigator or research agreement
A copy of the IRB letter approving the research registry
A copy of the IRB approved Patient Information and Consent form
All clinical forms and documentation, including:
a copy of the signed patient consent form
all supporting documentation for data entered into the EDC
records of any adverse device effects, including supporting documentation
records pertaining to patient deaths during the investigation
documentation and rationale for any deviations from the clinical protocol
any other records required by the sponsor
8.2 INVESTIGATOR REPORTS
The investigator is responsible for the accurate and timely preparation (review and/or 
signature) and submission of the reports cited below:
Withdrawal of IRB approval and the reason for withdrawal. An investigator should 
report to the sponsor, within 5 working days, a withdrawal of approval by the 
reviewing IRB of the site investigator’s participation in an investigation.
Informed consent. If an investigator enrolls a patient without obtaining informed 
consent, the investigator will report such enrollment to the sponsor and the 
reviewing IRB within 5 working days after the event occurs.
Notification of patient death during the post-approval registry
Annual progress reports prepared for the IRB

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Notification of any deviations from the investigational protocol
Final summary report prepared for the IRB
Other: an investigator will, upon request by a reviewing IRB, the FDA, or 
BIOTRONIK, provide accurate, complete, and current information about any 
aspect of the registry
The table below is a chart outlining the responsibilities, including time constraints, for
submitting the above reports.
Type of Report
Prepared by 
Investigator for:
Time Constraints of Notification
Patient Death During 
Investigation
BIOTRONIK, IRB
BIOTRONIK as soon as possible and 
as required by reviewing IRB
Patient Withdrawal
BIOTRONIK
Within 5 working days
Withdrawal of IRB 
Approval
BIOTRONIK
Within 5 working days
Progress Report
BIOTRONIK, IRB
Submitted not less than yearly
Significant Deviations 
from Investigational 
Plan
BIOTRONIK, IRB
Within 5 working days after 
emergency to protect life or physical 
well-being of the patient, otherwise 
prior approval by sponsor is required
Informed Consent Not 
Obtained
BIOTRONIK, IRB
Within 5 working days of use
Final Summary Report
BIOTRONIK, IRB
Within 3 months after completion or 
termination of the registry
8.3 SPONSOR RECORDS
The sponsor, BIOTRONIK, will maintain the following records:
All correspondence that pertains to the investigation with investigator(s), IRB, 
and FDA
Investigator agreements, financial disclosures, and current curriculum vitae
Name and address of each investigator and each IRB that is involved with the 
investigation
Adverse events and complaints
Electronic Case Report Form data
Completed patient Informed Consent Forms
Clinical investigational plan (protocol) and report of prior investigations
Monitoring reports
Clinical progress reports

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8.4 SPONSOR REPORTS
The sponsor is responsible for preparing the following reports:
Type of Report
Prepared by Sponsor 
for:
Time Constraints of Notification
Withdrawal of IRB 
Approval
FDA, all reviewing IRBs,
and participating 
investigators
Within 5 working days of receipt of 
notice of withdrawal of approval
Withdrawal of FDA 
Approval
Reviewing 
IRBs 
and 
participating 
investigators
Notification will be made within 5 
working days
Progress Report
FDA, all reviewing IRBs
A periodic progress report will be 
submitted every six months. The 
report will include:
All reported AEs
AE trend analysis
Patient accountability, 
including enrollment, and 
follow-up status
Recall and Disposition
FDA, all reviewing IRBs
Notification will be made within 30 
working days and will include the 
reasons for any request that an 
investigator return, repair or 
otherwise dispose of any devices
Final Report
FDA, all reviewing IRBs,
and participating 
investigators
Notify FDA within 30 working days 
of the completion or termination of 
the investigation. A final report will 
be submitted within 6 months after 
completion or termination of the 
registry.
Failure to Obtain 
Informed Consent
FDA
A copy of the investigator's report 
will be submitted within 5 working 
days of notification of use

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APPENDIX A: DEFINITION OF TERMS
AE (Adverse Event) - an unwanted effect detected in participants. The term is used 
whether or not the effect can be attributed to the leads in the registry. For the purposes 
of this registry, BIOTRONIK classifies an AE as either related to the Corox BP lead or 
not related to the lead.
ACC/AHA – American College of Cardiology/American Heart Association
Cardiac Perforation – Penetration of the lead tip through the myocardium (including 
microperforation), either clinically suspected or confirmed by chest x-ray, fluoroscopy, 
echocardiogram, intracardiac electrogram and/or visually
Clinical Failure – Inability of the Corox BP LV lead to correctly sense or pace in the 
heart, not attributable to a mechanical malfunction of the lead or pulse generator that 
remains unresolved despite reprogramming and/or repositioning. 
CFR – Code of Federal Regulations 
Conductor Fracture – See Lead Fracture
Confirmed Failure – A Corox BP LV lead having clinically relevant characteristics that 
are outside the performance limits established by BIOTRONIK while implanted and in 
service, as confirmed by analysis, except for changes in characteristics that are due to 
induced malfunctions. Lead damage caused during or after explant is not considered a 
failure.
Complication - an adverse event that requires additional invasive intervention to 
resolve
Coronary Sinus Dissection – A tear that occurs in the wall of the coronary sinus
Coronary Perforation - Penetration of the lead tip through the coronary sinus, either 
clinically suspected or confirmed by chest x-ray, fluoroscopy, echocardiogram, 
intracardiac electrogram and/or visually
CHF (Congestive Heart Failure) – a condition where the heart is not able to pump 
sufficient amounts of blood to meet the body’s need
CRT-P – Cardiac Resynchronization Therapy Pacemaker
CRT-D - Cardiac Resynchronization Therapy Defibrillator
Defibrillation Impedance – The total opposition of current that presents in the circuit 
utilized to shock an arrhythmic heart back into a normal rhythm. Defibrillation 
impedance is considered abnormal if the measurement is 
20 Ohms or 
200 Ohms
Diaphragmatic/Pectoral 
Stimulation 
–
Clinical 
observation 
of 
inadvertent 
nerve/muscle stimulation other than cardiac muscle.
eCRF – electronic Case Report Form
EDC – Electronic Data Capture system

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Elevated Threshold – Either of the following definitions constitute an Elevated 
Threshold:
1. At implant, pacing thresholds for the permanently programmed electrode that are 
greater than 3.0 Volts at 0.5 ms., or
2. At follow-up, pacing thresholds for the permanently programmed electrode that 
are greater than 3.5 Volts at 0.5 ms.
ERI – Elective Replacement Indicator
Exit Block – The failure of an intact pacing system to capture the heart because the 
stimulation threshold exceeds the output of the pacemaker
Explanted (LV Lead) – Surgical removal of an LV lead during the acute implant stage, 
whereby the lead has not been chronically implanted and can be easily removed by 
simple traction
Extracted (LV Lead) - Surgical removal of a chronically implanted LV lead 
Failure to Capture or Loss of Capture – Intermittent or complete failure to achieve 
cardiac stimulation at programmed output delivered outside of the cardiac refractory 
period
High Pacing Threshold – Sudden and significant increase compared to the previous 
measured threshold value
IDE – Investigational Device Exemption
Insulation Breach/Break – Visual, electrical, or radiographic evidence of a disruption 
or break in the insulation of a lead
IRB – Investigational Review Board
Lead 
Dislodgment 
or 
Lead 
Migration 
–
Radiographic, 
electrical 
or 
electrocardiographic evidence of electrode displacement from the original implant site or 
electrode displacement that adversely affects pacing, and/or lead performance
Lead Fracture – Visual, electrical and/or radiographic evidence of mechanical break 
within the lead conductor (connectors, coils and/or electrodes)
Lead impedance out of range – Pacing impedance is considered abnormal if a 
measurement is 
200 Ohms or 
2000 Ohms
Loss of Sensing/Undersensing– Intermittent or complete failure to sense any intrinsic 
events that occur outside the programmed refractory periods at programmed sensitivity 
settings
LV – Left Ventricular
LV Lead Abandoned, CRT programmed off – The LV lead remains connected to the 
generator but LV pacing is disabled
Non-healing Pocket Dehiscence – Separation of wound edges around the pocket of 
the implanted pulse generator that have not healed

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NYHA – New York Heart Association, a recognized system of classifying patient 
condition according to:
I – Ordinary physical activity does not cause undue fatigue, palpitation, 
dyspnea, or anginal pain
II – Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal 
pain
III – Less than ordinary physical activity causes fatigue, palpitation, dyspnea or 
anginal pain
IV – Symptoms of cardiac insufficiency or of the anginal syndrome may be 
present even at rest. If any physical activity is undertaken, discomfort is 
increased
Observation – an adverse event that does not require additional invasive intervention 
to resolve
Oversensing –
Misinterpretation of cardiac or non-cardiac events as cardiac 
depolarization, such as T waves, skeletal muscle potentials, and extracardiac 
electromagnetic interference (EMI)
PG (Pulse Generator) – For this registry, the pulse generator must be either a 
BIOTRONIK CRT-P or CRT-D
Pneumothorax – Air or fluid in the pleural space surrounding the lung leading to 
collapse or partial collapse of the lung
Premature Battery Depletion – Reaching Elective Replacement indicator (ERI) before 
the predicted date
Mechanical Failure – Malfunction of the Corox BP LV lead through a break in the 
conductor, insulation or connector pin leading to loss of CRT therapy
RV/RA/ICD lead – Right Ventricular/ Right Atrial/ Implantable Cardioverter Defibrillator 
Lead
Significant Increase in Pacing Threshold – One of the following definitions must be 
met:
1. An observed increase of 2-fold over the first chronic threshold, provided that the 
resultant threshold is greater than 5 Volts at 0.5 ms, or
2. An observed threshold higher than the maximum output of the device. Currently, 
this is 7.5 V at 1.5 ms in the Lumax 340 HF-T and Lumax 540 HF-T CRT-D’s.
Chronic threshold is defined as the pacing threshold determined at the patient’s 3 month 
follow-up visit.
Skin Erosion – Deterioration of tissue over an implanted device or the movement of a 
lead toward or through the skin
Suspected Generator Failure – Pulse generator issue that is potentially an electrical 
malfunction

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Suspected Lead Failure – Corox BP LV Lead issue that is potentially a mechanical or 
electrical malfunction
Tamponade – Compression of the heart caused by blood accumulation in the space 
between the myocardium and the pericardium
Threshold Rise – An observed threshold increase of 2-fold over the first chronic 
threshold, provided that the resultant threshold is greater than 3.5 Volts at 0.5 ms. 
Chronic threshold is defined as the pacing threshold determined at the patient’s 3 month 
follow-up visit.
Thrombosis – The development of a blood clot in a vein or artery
Twiddler’s Syndrome – A condition where the pulse generator leads are dislodged by 
the patient unwittingly rotating the subcutaneous pulse generator

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APPENDIX B: TIMELINE
CELESTIAL Post-Approval Registry Timeline
While BIOTRONIK has legally marketed and sold cardiac rhythm management devices 
for many years, Cardiac Resynchronization Therapy is a relatively new field for 
BIOTRONIK. Creating a timeline that characterizes patient enrollment where market-
share is not clearly understood is challenging, and therefore BIOTRONIK has made the 
following assumptions:
FDA protocol approval by November 8, 2008
Ability to recruit sufficient number of interested centers and enroll 2500 patients 
within 24 months
10% local IRB, 90% central IRB
In addition, BIOTRONIK assumes the approximate timeline:
CELESTIAL Post-Approval Registry Timeline Estimate
Date
FDA Approval of the Corox BP LV Leads (P070008)
May 12, 2008
BIOTRONIK Submission of CELESTIAL Post-Approval Registry
June 10, 2008
FDA Approval of CELESTIAL Post-Approval Registry
November 06, 2008
First IRB Approval
December 08, 2008
First Patient Enrolled
December 19, 2008
5 Clinical Sites open, 19 patients enrolled
February 14, 2009
CELESTIAL 6 Month Interim Post-Approval Registry Status Report submitted
May 08, 2009
50 Sites open, 223 patients enrolled
August 15, 2009
CELESTIAL 12 Month Interim Post-Approval Registry Status Report submitted
November 08, 2009
50-75 Sites open, 541 patients enrolled
February 13, 2010
CELESTIAL 18 Month Interim Post-Approval Registry Status Report submitted
May 08, 2010
50-75 Sites open, 825 patients enrolled 
August 12, 2010
CELESTIAL 24 Month Interim Post-Approval Registry Status Report submitted
November 08, 2010
50-75 Sites open, 1104 patients enrolled
December 19, 2010
CELESTIAL 30 Month Interim Post-Approval Registry Status Report submitted
May 08, 2011
75-100 Sites open, 1404 patients enrolled
May 08, 2011
CELESTIAL 36 Month Interim Post-Approval Registry Status Report submitted
November 08, 2011
75-100 Sites open, 1854 patients enrolled
November 08, 2011
75-100 Sites open, 2000 patients enrolled
February 08, 2012
CELESTIAL 42 Month Interim Post-Approval Registry Status Report submitted
May 08, 2012
75-100 Sites open, 2225 patients enrolled
May 08, 2012
75-100 Sites open, 2500 patients enrolled
August 29, 2012
CELESTIAL 48 Month Interim Post-Approval Registry Status Report submitted
November 08, 2012
CELESTIAL 54 Month Interim Post-Approval Registry Status Report submitted
May 08, 2013
CELESTIAL 60 Month Interim Post-Approval Registry Status Report submitted
November 08, 2013
CELESTIAL 66 Month Interim Post-Approval Registry Status Report submitted
May 08, 2014
CELESTIAL 72 Month Interim Post-Approval Registry Status Report submitted
November 08, 2014
CELESTIAL 78 Month Interim Post-Approval Registry Status Report submitted
May 08, 2015
CELESTIAL 84 Month Interim Post-Approval Registry Status Report submitted
November 08, 2015
CELESTIAL 90 Month Interim Post-Approval Registry Status Report submitted
May 08, 2016
CELESTIAL 96 Month Interim Post-Approval Registry Status Report submitted
November 08, 2016
CELESTIAL 102 Month Interim Post-Approval Registry Status Report submitted
May 08, 2017
CELESTIAL Final Post-Approval Registry Status Report submitted
November 08, 2017