CELESTIAL: Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00810264
• Collaborator: (none)
• Enrollment: 2,499
• Locations: 86
• Duration (Months): 119
• Patients Per Site: 29.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Device: CRT Therapy - LV Lead Registry

Detailed Description

This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval registry, and each patient will be followed for five years post-implant.

Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.

Study Design

• Study Type: Observational
• Actual Enrollment: 2499 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Nov 2, 2018
• Actual Study Completion Date: Nov 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Data Collection Group	Device: CRT Therapy - LV Lead Registry; Collecting long-term safety and efficacy data on a market-released left ventricular lead.

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead [5 years]

   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.This was evaluated as a serious adverse event free-rate (SAEFR).

2. Percentage of Subjects Experiencing Individual Complications [5 years]

   Evaluation of the individual types of serious adverse events contributing to primary outcome 1.

Secondary Outcome Measures

1. Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. [5 years]

   Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.

2. Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint [5 years]

   Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.

3. Corox BP LV Lead Pacing Threshold Measurements [5 years]

   Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

4. Corox BP LV Lead Sensing Measurements [5 years]

   Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

5. Corox BP LV Lead Impedance Measurements [5 years]

   Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

6. Pacing Threshold Measurements Per Corox BP LV Lead Model [5 years]

   Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

7. Sensing Measurements Per Corox BP LV Lead Model [5 years]

   Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

8. Impedance Measurements Per Corox BP LV Lead Model [5 years]

   Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

9. Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model [5 years]

   Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.

10. Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model [5 years]

    Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• Available for follow-up visits on a regular basis at the investigational site

• Age greater than or equal to 18 years

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Glendale	Arizona	United States
3		Mesa	Arizona	United States
4		Phoenix	Arizona	United States
5		Scottsdale	Arizona	United States
6		Tucson	Arizona	United States
7		Anaheim	California	United States
8		Fairfield	California	United States
9		Fountain Valley	California	United States
10		Glendale	California	United States
11		Hawthorne	California	United States
12		Inglewood	California	United States
13		Los Angeles	California	United States
14		National City	California	United States
15		Northridge	California	United States
16		Orange	California	United States
17		Rancho Mirage	California	United States
18		Santa Barbara	California	United States
19		Torrance	California	United States
20		Ventura	California	United States
21		Watsonville	California	United States
22		Aurora	Colorado	United States
23		Boulder	Colorado	United States
24		Danbury	Connecticut	United States
25		Brooksville	Florida	United States
26		Davenport	Florida	United States
27		Melbourne	Florida	United States
28		Naples	Florida	United States
29		New Smyrna Beach	Florida	United States
30		Saint Petersburg	Florida	United States
31		Tampa	Florida	United States
32		Macon	Georgia	United States
33		Urbana	Illinois	United States
34		Fort Wayne	Indiana	United States
35		Valparaiso	Indiana	United States
36		Owensboro	Kentucky	United States
37		Covington	Louisiana	United States
38		Hammond	Louisiana	United States
39		Lafayette	Louisiana	United States
40		Bangor	Maine	United States
41		Baltimore	Maryland	United States
42		Cumberland	Maryland	United States
43		Lanham	Maryland	United States
44		Rockville	Maryland	United States
45		Burlington	Massachusetts	United States
46		Worcester	Massachusetts	United States
47		Ann Arbor	Michigan	United States
48		Lansing	Michigan	United States
49		Lapeer	Michigan	United States
50		Saginaw	Michigan	United States
51		Wyoming	Michigan	United States
52		Ypsilanti	Michigan	United States
53		Tupelo	Mississippi	United States
54		Crystal City	Missouri	United States
55		Saint Louis	Missouri	United States
56		Las Vegas	Nevada	United States
57		Glen Ridge	New Jersey	United States
58		New York	New York	United States
59		Rochester	New York	United States
60		Gastonia	North Carolina	United States
61		Winston-Salem	North Carolina	United States
62		Columbus	Ohio	United States
63		Middletown	Ohio	United States
64		Steubenville	Ohio	United States
65		Toledo	Ohio	United States
66		Oklahoma City	Oklahoma	United States
67		Salem	Oregon	United States
68		Chinchilla	Pennsylvania	United States
69		Lancaster	Pennsylvania	United States
70		Philadelphia	Pennsylvania	United States
71		Pottstown	Pennsylvania	United States
72		Yardley	Pennsylvania	United States
73		Columbia	South Carolina	United States
74		Greenville	South Carolina	United States
75		Spartanburg	South Carolina	United States
76		Chattanooga	Tennessee	United States
77		Amarillo	Texas	United States
78		Brownsville	Texas	United States
79		Corpus Christi	Texas	United States
80		Dallas	Texas	United States
81		Kingwood	Texas	United States
82		McKinney	Texas	United States
83		Nacogdoches	Texas	United States
84		Fredericksburg	Virginia	United States
85		Spokane	Washington	United States
86		Yakima	Washington	United States

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 16, 2010
• Statistical Analysis Plan - Apr 26, 2019

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT00810264
• Other Study ID Numbers: CELESTIAL
• First Posted: Dec 18, 2008
• Last Update Posted: Nov 29, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Biotronik, Inc.: Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Period Title: Overall Study
STARTED	2499
COMPLETED	946
NOT COMPLETED	1553

Baseline Characteristics

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Participants	2498
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.4 (11.4)
Sex: Female, Male (Count of Participants)
Female	724 29%
Male	1774 71%
Race/Ethnicity, Customized (Count of Participants)
White	1805 72.3%
Hispanic or Latino	244 9.8%
Black or African American	220 8.8%
Asian	36 1.4%
Native Hawaiian or Other Pacific Islander	7 0.3%
American Indian or Alaska Native	4 0.2%
Unknown	65 2.6%
Not Reported	117 4.7%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	67.7 (4.2)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	194.4 (48.1)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
Description	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.This was evaluated as a serious adverse event free-rate (SAEFR).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	946
Number (95% Confidence Interval) [percentage of subjects]	94.19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BIOTRONIK Corox BP LV Lead
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Binomial Proportion
	Comments

2. Primary Outcome

Title	Percentage of Subjects Experiencing Individual Complications
Description	Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	946
Lead dislodgement (>180 days post-implant)	3.28
Abnormal pacing impedance	1.90
Conductor fracture	0.53
Malposition, excess slack	0.11

3. Secondary Outcome

Title	Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
Description	Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The subjects analyzed in this outcome must have been consented, implanted with a BIOTRONIK Corox BP LV lead, and completed an in-office 5 year visit. Subjects who did not complete an in-office 5 year visit are excluded from this analysis population.

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead completing an in-office 5 year visit.
Measure Participants	611
Mean (Standard Deviation) [percentage of CRT pacing]	97.4 (8.4)

4. Secondary Outcome

Title	Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Description	Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	2499
LV lead cardiac perforation	0.04
LV lead high pacing threshold, no lead capture	0.96
LV lead diaphragmatic / pectoral stimulation	1.00
LV lead dislodgement (<180 days post-implant)	1.64
RV pacing lead related adverse event	0.16
Device related adverse event	0.28
Other adverse event	1.36
RA lead related adverse event	2.08
Implant procedure related adverse event	3.20
ICD lead related adverse event	3.96
Other high pacing threshold	0.04

5. Secondary Outcome

Title	Corox BP LV Lead Pacing Threshold Measurements
Description	Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	2499
Mean (Standard Deviation) [V]	1.41 (1.09)

6. Secondary Outcome

Title	Corox BP LV Lead Sensing Measurements
Description	Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	2499
Mean (Standard Deviation) [mV]	13.94 (7.51)

7. Secondary Outcome

Title	Corox BP LV Lead Impedance Measurements
Description	Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Measure Participants	2499
Mean (Standard Deviation) [ohms]	726.5 (250.9)

8. Secondary Outcome

Title	Pacing Threshold Measurements Per Corox BP LV Lead Model
Description	Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corox OTW BP	Corox OTW-S BP	Corox OTW-L BP
Arm/Group Description	Subjects consented and originally implanted with a Corox OTW BP lead.	Subjects consented and originally implanted with a Corox OTW-S BP lead.	Subjects consented and originally implanted with a Corox OTW-L BP lead.
Measure Participants	686	1129	684
Mean (Standard Deviation) [V]	1.30 (1.01)	1.40 (1.09)	1.53 (1.17)

9. Secondary Outcome

Title	Sensing Measurements Per Corox BP LV Lead Model
Description	Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corox OTW BP	Corox OTW-S BP	Corox OTW-L BP
Arm/Group Description	Subjects consented and originally implanted with a Corox OTW BP lead.	Subjects consented and originally implanted with a Corox OTW-S BP lead.	Subjects consented and originally implanted with a Corox OTW-L BP lead.
Measure Participants	686	1129	684
Mean (Standard Deviation) [mV]	14.82 (7.74)	13.94 (7.59)	13.04 (7.02)

10. Secondary Outcome

Title	Impedance Measurements Per Corox BP LV Lead Model
Description	Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corox OTW BP	Corox OTW-S BP	Corox OTW-L BP
Arm/Group Description	Subjects consented and originally implanted with a Corox OTW BP lead.	Subjects consented and originally implanted with a Corox OTW-S BP lead.	Subjects consented and originally implanted with a Corox OTW-L BP lead.
Measure Participants	686	1129	684
Mean (Standard Deviation) [ohms]	730.3 (264.9)	734.4 (251.7)	709.2 (233.1)

11. Secondary Outcome

Title	Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model
Description	Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.

Arm/Group Title	Corox OTW BP	Corox OTW-S BP	Corox OTW-L BP
Arm/Group Description	Subjects consented and originally implanted with a Corox OTW BP lead.	Subjects consented and originally implanted with a Corox OTW-S BP lead.	Subjects consented and originally implanted with a Corox OTW-L BP lead.
Measure Participants	279	401	266
Number (95% Confidence Interval) [percentage of subjects]	7.17	6.48	3.38

12. Secondary Outcome

Title	Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Description	Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.

Arm/Group Title	Corox OTW BP	Corox OTW-S BP	Corox OTW-L BP
Arm/Group Description	Subjects consented and originally implanted with a Corox OTW BP lead.	Subjects consented and originally implanted with a Corox OTW-S BP lead.	Subjects consented and originally implanted with a Corox OTW-L BP lead.
Measure Participants	279	401	266
Lead dislodgement (>180 days post-implant)	3.58	3.49	2.63
Abnormal pacing impedance	1.79	2.99	0.38
Conductor fracture	1.79	0	0
Malposition, excess slack	0	0	0.38

Adverse Events

Time Frame	Implant to study exit (up to 5 years post-implant)
Arm/Group Title	BIOTRONIK Corox BP LV Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
All Cause Mortality
	BIOTRONIK Corox BP LV Lead
	Affected / at Risk (%)	# Events
Total	641/2499 (25.7%)
Serious Adverse Events
	BIOTRONIK Corox BP LV Lead
	Affected / at Risk (%)	# Events
Total	281/2499 (11.2%)
Cardiac disorders
CHF	1/2499 (0%)	1
Device migration	2/2499 (0.1%)	2
Hypotensive arrest / hemodynamic collapse	1/2499 (0%)	1
ICD lead T-wave oversensing	1/2499 (0%)	1
ICD lead cardiac perforation with or without tamponade	1/2499 (0%)	1
ICD lead dislodgement	34/2499 (1.4%)	34
ICD lead high pacing threshold, intermittent capture, no lead capture	14/2499 (0.6%)	14
ICD lead impedance out of range, high impedance, potential conductor fracture	15/2499 (0.6%)	15
ICD lead impedance out of range, low Impedance, potential insulation break	11/2499 (0.4%)	11
ICD lead inability to defibrillate or pace	1/2499 (0%)	1
ICD lead oversensing or lead noise	10/2499 (0.4%)	10
ICD lead undersensing or loss of sensing	1/2499 (0%)	1
ICD lead, Riata lead externalized	2/2499 (0.1%)	2
ICD lead, unknown, inadequate source documentation	1/2499 (0%)	1
Inappropriate shocks	1/2499 (0%)	1
LV lead abnormal pacing impedance, high impedance	12/2499 (0.5%)	12
LV lead cardiac perforation with or without tamponade	1/2499 (0%)	1
LV lead conductor fracture	5/2499 (0.2%)	5
LV lead dislodgement	61/2499 (2.4%)	65
LV lead excess slack	1/2499 (0%)	1
LV lead high pacing threshold, intermittent capture, no lead capture	14/2499 (0.6%)	14
LV lead related diaphgramatic / pectoral stimulation	14/2499 (0.6%)	14
Non-functioning RA lead	1/2499 (0%)	1
Pocket pain	1/2499 (0%)	1
RA lead dislodgement	29/2499 (1.2%)	30
RA lead high pacing threshold, intermittent capture, no lead capture	3/2499 (0.1%)	3
RA lead impedance out of range, high impedance, potential conductor fracture	8/2499 (0.3%)	8
RA lead impedance out of range, low impedance, potential insulation break	1/2499 (0%)	1
RA lead oversensing or lead noise	1/2499 (0%)	1
RA lead undersensing or loss of sensing	2/2499 (0.1%)	2
RV pacing lead dislodgement	2/2499 (0.1%)	2
RV pacing lead impedance out of range, high impedance, potential conductor fracture	1/2499 (0%)	1
RV pacing lead noise	1/2499 (0%)	1
Suspected generator failure requiring opening of pulse generator pocket	1/2499 (0%)	1
General disorders
Twiddler's syndrome	7/2499 (0.3%)	9
Infections and infestations
Implant procedure related infection	19/2499 (0.8%)	19
Pocket infection	2/2499 (0.1%)	2
Secondary infection	15/2499 (0.6%)	15
Skin and subcutaneous tissue disorders
Skin erosion	3/2499 (0.1%)	3
Trauma related dehiscence	2/2499 (0.1%)	2
Surgical and medical procedures
Cardiac perforation with or without tamponade	1/2499 (0%)	1
Hematoma	15/2499 (0.6%)	15
High defibrillation thresholds due to inappropriate lead placement	1/2499 (0%)	1
Implant procedure related damage to the lead	1/2499 (0%)	1
LV lead dislodgement during RV lead extraction	1/2499 (0%)	1
Loose set screw	5/2499 (0.2%)	5
Non-healing pocket dehiscence requiring intervention	8/2499 (0.3%)	8
Open heart surgery causing LV lead dislodgement	1/2499 (0%)	1
Persistent arm of unknown cause	1/2499 (0%)	1
Pneumothorax	2/2499 (0.1%)	2
Pocket pain	2/2499 (0.1%)	2
RA lead dislodgement during LV lead placement	1/2499 (0%)	1
SVC perforation during laser lead extraction	1/2499 (0%)	1
Subclavian vein occlusion	1/2499 (0%)	1
Other (Not Including Serious) Adverse Events
	BIOTRONIK Corox BP LV Lead
	Affected / at Risk (%)	# Events
Total	83/2499 (3.3%)
Cardiac disorders
ICD lead high pacing threshold, intermittent capture, no lead capture	2/2499 (0.1%)	2
ICD lead oversensing	2/2499 (0.1%)	2
ICD lead oversensing or lead noise	4/2499 (0.2%)	4
LV lead abnormal pacing impedance, high impedance	7/2499 (0.3%)	7
LV lead dislodgement	9/2499 (0.4%)	9
High pacing threshold	1/2499 (0%)	1
LV lead high pacing threshold, intermittent capture, no lead capture	10/2499 (0.4%)	10
LV lead related diaphgramatic / pectoral stimulation	11/2499 (0.4%)	11
RA lead dislodgement	1/2499 (0%)	1
RA lead high pacing threshold, intermittent capture, no lead capture	3/2499 (0.1%)	3
RA lead impedance out of range, high impedance, potential conductor fracture	1/2499 (0%)	1
RA lead impedance out of range, low impedance, potential insulation break	1/2499 (0%)	1
RA lead noise	1/2499 (0%)	1
RA lead oversensing or lead noise	1/2499 (0%)	1
Twiddler's syndrome	1/2499 (0%)	1
Surgical and medical procedures
Arrhythmias	1/2499 (0%)	1
Coronary sinus dissection	3/2499 (0.1%)	3
Diaphragmatic stimulation	1/2499 (0%)	1
Hematoma	22/2499 (0.9%)	22
Incompletely healed incision	1/2499 (0%)	1
Left subclavian vein thrombosis	1/2499 (0%)	1
Non-healing pocket dehiscence requiring intervention	1/2499 (0%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.