Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00810264
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Congestive Heart Failure
Intervention Device: CRT Therapy - LV Lead Registry
Enrollment 2499
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide 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
Reason Not Completed
Lost to Follow-up             191
Withdrawal by subject or physician             721
Death             641
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide Arm/Group Description Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Baseline Participants 2498
Hide Baseline Analysis Population Description
Baseline characteristics are provided when available, subjects without available baseline characteristics are not included in the number of participants analyzed in this section.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2498 participants
70.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2498 participants
Female
724
  29.0%
Male
1774
  71.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2498 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  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 2498 participants
67.7  (4.2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 2498 participants
194.4  (48.1)
1.Primary Outcome
Title Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 946
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
94.19
(92.50 to 95.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIOTRONIK Corox BP LV Lead
Comments [Not Specified]
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 [Not Specified]
Method Binomial Proportion
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects Experiencing Individual Complications
Hide Description Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
Time Frame 5 years
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 946
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Lead dislodgement (>180 days post-implant)
3.28
(2.24 to 4.62)
Abnormal pacing impedance
1.90
(1.13 to 2.99)
Conductor fracture
0.53
(0.17 to 1.23)
Malposition, excess slack
0.11
(0.00 to 0.59)
3.Secondary Outcome
Title Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead completing an in-office 5 year visit.
Overall Number of Participants Analyzed 611
Mean (Standard Deviation)
Unit of Measure: percentage of CRT pacing
97.4  (8.4)
4.Secondary Outcome
Title Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Hide Description Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 2499
Measure Type: Number
Unit of Measure: Percent of subjects
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 2499
Mean (Standard Deviation)
Unit of Measure: V
1.41  (1.09)
6.Secondary Outcome
Title Corox BP LV Lead Sensing Measurements
Hide Description Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 2499
Mean (Standard Deviation)
Unit of Measure: mV
13.94  (7.51)
7.Secondary Outcome
Title Corox BP LV Lead Impedance Measurements
Hide Description Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide Arm/Group Description:
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
Overall Number of Participants Analyzed 2499
Mean (Standard Deviation)
Unit of Measure: ohms
726.5  (250.9)
8.Secondary Outcome
Title Pacing Threshold Measurements Per Corox BP LV Lead Model
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Corox OTW BP Corox OTW-S BP Corox OTW-L BP
Hide 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.
Overall Number of Participants Analyzed 686 1129 684
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Corox OTW BP Corox OTW-S BP Corox OTW-L BP
Hide 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.
Overall Number of Participants Analyzed 686 1129 684
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Corox OTW BP Corox OTW-S BP Corox OTW-L BP
Hide 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.
Overall Number of Participants Analyzed 686 1129 684
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 279 401 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
7.17
(4.43 to 10.85)
6.48
(4.28 to 9.36)
3.38
(1.56 to 6.33)
12.Secondary Outcome
Title Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 279 401 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Lead dislodgement (>180 days post-implant)
3.58
(1.73 to 6.49)
3.49
(1.92 to 5.79)
2.63
(1.06 to 5.35)
Abnormal pacing impedance
1.79
(0.58 to 4.13)
2.99
(1.56 to 5.17)
0.38
(0.01 to 2.08)
Conductor fracture
1.79
(0.58 to 4.13)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Malposition, excess slack
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0.38
(0.01 to 2.08)
[1]
Unable to obtain confidence interval for 0 subjects
Time Frame Implant to study exit (up to 5 years post-implant)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIOTRONIK Corox BP LV Lead
Hide 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 (%)
Total   641/2499 (25.65%)    
Hide Serious Adverse Events
BIOTRONIK Corox BP LV Lead
Affected / at Risk (%) # Events
Total   281/2499 (11.24%)    
Cardiac disorders   
CHF   1/2499 (0.04%)  1
Device migration   2/2499 (0.08%)  2
Hypotensive arrest / hemodynamic collapse   1/2499 (0.04%)  1
ICD lead T-wave oversensing   1/2499 (0.04%)  1
ICD lead cardiac perforation with or without tamponade   1/2499 (0.04%)  1
ICD lead dislodgement   34/2499 (1.36%)  34
ICD lead high pacing threshold, intermittent capture, no lead capture   14/2499 (0.56%)  14
ICD lead impedance out of range, high impedance, potential conductor fracture   15/2499 (0.60%)  15
ICD lead impedance out of range, low Impedance, potential insulation break   11/2499 (0.44%)  11
ICD lead inability to defibrillate or pace   1/2499 (0.04%)  1
ICD lead oversensing or lead noise   10/2499 (0.40%)  10
ICD lead undersensing or loss of sensing   1/2499 (0.04%)  1
ICD lead, Riata lead externalized   2/2499 (0.08%)  2
ICD lead, unknown, inadequate source documentation   1/2499 (0.04%)  1
Inappropriate shocks   1/2499 (0.04%)  1
LV lead abnormal pacing impedance, high impedance   12/2499 (0.48%)  12
LV lead cardiac perforation with or without tamponade   1/2499 (0.04%)  1
LV lead conductor fracture   5/2499 (0.20%)  5
LV lead dislodgement   61/2499 (2.44%)  65
LV lead excess slack   1/2499 (0.04%)  1
LV lead high pacing threshold, intermittent capture, no lead capture   14/2499 (0.56%)  14
LV lead related diaphgramatic / pectoral stimulation   14/2499 (0.56%)  14
Non-functioning RA lead   1/2499 (0.04%)  1
Pocket pain   1/2499 (0.04%)  1
RA lead dislodgement   29/2499 (1.16%)  30
RA lead high pacing threshold, intermittent capture, no lead capture   3/2499 (0.12%)  3
RA lead impedance out of range, high impedance, potential conductor fracture   8/2499 (0.32%)  8
RA lead impedance out of range, low impedance, potential insulation break   1/2499 (0.04%)  1
RA lead oversensing or lead noise   1/2499 (0.04%)  1
RA lead undersensing or loss of sensing   2/2499 (0.08%)  2
RV pacing lead dislodgement   2/2499 (0.08%)  2
RV pacing lead impedance out of range, high impedance, potential conductor fracture   1/2499 (0.04%)  1
RV pacing lead noise   1/2499 (0.04%)  1
Suspected generator failure requiring opening of pulse generator pocket   1/2499 (0.04%)  1
General disorders   
Twiddler's syndrome   7/2499 (0.28%)  9
Infections and infestations   
Implant procedure related infection   19/2499 (0.76%)  19
Pocket infection   2/2499 (0.08%)  2
Secondary infection   15/2499 (0.60%)  15
Skin and subcutaneous tissue disorders   
Skin erosion   3/2499 (0.12%)  3
Trauma related dehiscence   2/2499 (0.08%)  2
Surgical and medical procedures   
Cardiac perforation with or without tamponade   1/2499 (0.04%)  1
Hematoma   15/2499 (0.60%)  15
High defibrillation thresholds due to inappropriate lead placement   1/2499 (0.04%)  1
Implant procedure related damage to the lead   1/2499 (0.04%)  1
LV lead dislodgement during RV lead extraction   1/2499 (0.04%)  1
Loose set screw   5/2499 (0.20%)  5
Non-healing pocket dehiscence requiring intervention   8/2499 (0.32%)  8
Open heart surgery causing LV lead dislodgement   1/2499 (0.04%)  1
Persistent arm of unknown cause   1/2499 (0.04%)  1
Pneumothorax   2/2499 (0.08%)  2
Pocket pain   2/2499 (0.08%)  2
RA lead dislodgement during LV lead placement   1/2499 (0.04%)  1
SVC perforation during laser lead extraction   1/2499 (0.04%)  1
Subclavian vein occlusion   1/2499 (0.04%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIOTRONIK Corox BP LV Lead
Affected / at Risk (%) # Events
Total   83/2499 (3.32%)    
Cardiac disorders   
ICD lead high pacing threshold, intermittent capture, no lead capture   2/2499 (0.08%)  2
ICD lead oversensing   2/2499 (0.08%)  2
ICD lead oversensing or lead noise   4/2499 (0.16%)  4
LV lead abnormal pacing impedance, high impedance   7/2499 (0.28%)  7
LV lead dislodgement   9/2499 (0.36%)  9
High pacing threshold   1/2499 (0.04%)  1
LV lead high pacing threshold, intermittent capture, no lead capture   10/2499 (0.40%)  10
LV lead related diaphgramatic / pectoral stimulation   11/2499 (0.44%)  11
RA lead dislodgement   1/2499 (0.04%)  1
RA lead high pacing threshold, intermittent capture, no lead capture   3/2499 (0.12%)  3
RA lead impedance out of range, high impedance, potential conductor fracture   1/2499 (0.04%)  1
RA lead impedance out of range, low impedance, potential insulation break   1/2499 (0.04%)  1
RA lead noise   1/2499 (0.04%)  1
RA lead oversensing or lead noise   1/2499 (0.04%)  1
Twiddler's syndrome   1/2499 (0.04%)  1
Surgical and medical procedures   
Arrhythmias   1/2499 (0.04%)  1
Coronary sinus dissection   3/2499 (0.12%)  3
Diaphragmatic stimulation   1/2499 (0.04%)  1
Hematoma   22/2499 (0.88%)  22
Incompletely healed incision   1/2499 (0.04%)  1
Left subclavian vein thrombosis   1/2499 (0.04%)  1
Non-healing pocket dehiscence requiring intervention   1/2499 (0.04%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Studies Engineer Group Manager
Organization: BIOTRONIK
Phone: 800-547-0394
EMail: celestial@biotronik.com
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00810264    
Other Study ID Numbers: CELESTIAL
First Submitted: December 17, 2008
First Posted: December 18, 2008
Results First Submitted: October 8, 2019
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2019