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Trial record 2 of 2 for:    qp excels

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

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ClinicalTrials.gov Identifier: NCT02290028
Recruitment Status : Terminated (BIOTRONIK received FDA approval to transition the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.)
First Posted : November 13, 2014
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Heart Failure
Intervention Device: Sentus QP left ventricular lead
Enrollment 2226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D, plus participants that were consented but did not receive a Sentus QP lead or CRT-D.
Period Title: Overall Study
Started 2226
Completed 0
Not Completed 2226
Reason Not Completed
Death             217
Sentus lead or required CRT-D was not implanted             186
No longer under care of study physician             76
Sentus lead or required CRT-D explanted             55
Withdrawal by Subject             52
Study site closure             44
Lost to Follow-up             34
Miscellaneous             10
Transition to EP PASSION             1295
Planned study completion at 12 months             257
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Baseline Participants 2222
Hide Baseline Analysis Population Description
All participants consented with baseline data collection completed
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2221 participants
68.8  (10.8)
[1]
Measure Analysis Population Description: Data collected and analyzed when available, not all subjects had data available for this measurement
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2222 participants
Female
683
  30.7%
Male
1539
  69.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 2198 participants
68.0  (4.0)
[1]
Measure Analysis Population Description: Data collected and analyzed when available, not all subjects had data available for this measurement
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 2208 participants
197.3  (50.0)
[1]
Measure Analysis Population Description: Data collected and analyzed when available, not all subjects had data available for this measurement
1.Primary Outcome
Title Sentus QP Related Complication-free Rate Through 6 Months
Hide Description The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 279
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.1
(94.4 to 98.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sentus QP Left Ventricular Lead
Comments Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact, binomial
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months
Hide Description The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant or with available data from remote monitoring or next visits (as pre-specified in the protocol).
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 286
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.4
(89.8 to 96.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sentus QP Left Ventricular Lead
Comments Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.002
Comments [Not Specified]
Method Exact, binomial
Comments [Not Specified]
3.Primary Outcome
Title Sentus QP Related Complication-free Rate
Hide Description The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 1727
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.03
(97.38 to 98.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sentus QP Left Ventricular Lead
Comments Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%
Type of Statistical Test Superiority
Comments [Not Specified]
Other Statistical Analysis On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.
4.Secondary Outcome
Title Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model
Hide Description The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant.
Arm/Group Title Sentus QP L Model Left Ventricular Lead Sentus QP S Model Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.
Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 240 36
Measure Type: Count of Participants
Unit of Measure: Participants
226
  94.2%
32
  88.9%
5.Secondary Outcome
Title Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months
Hide Description The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed novel vector threshold testing at 3 months post-implant.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 273
Measure Type: Count of Participants
Unit of Measure: Participants
261
  95.6%
6.Secondary Outcome
Title Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model
Hide Description The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed sensing test at 3 months post-implant.
Arm/Group Title Sentus QP L Model Left Ventricular Lead Sentus QP S Model Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.
Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 223 32
Measure Type: Count of Participants
Unit of Measure: Participants
223
 100.0%
32
 100.0%
7.Secondary Outcome
Title Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model
Hide Description The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed impedance testing at 3 months post-implant.
Arm/Group Title Sentus QP L Model Left Ventricular Lead Sentus QP S Model Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.
Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 245 36
Measure Type: Count of Participants
Unit of Measure: Participants
245
 100.0%
36
 100.0%
8.Secondary Outcome
Title Sentus QP Time to Complication
Hide Description The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 279
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.1
(95.14 to 99.13)
9.Secondary Outcome
Title Sentus QP Related Complication-free Rate Per Lead Model
Hide Description The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.
Arm/Group Title Sentus QP L Model Left Ventricular Lead Sentus QP S Model Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.
Participants consented and implanted with a Sentus QP S model left ventricular lead CRT-D.
Overall Number of Participants Analyzed 1306 421
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.47
(97.80 to 99.13)
96.67
(94.96 to 98.39)
10.Secondary Outcome
Title Individual Sentus QP Adverse Event Rates
Hide Description The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 1727
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Dislodgements
1.39
(0.08 to 1.94)
Extracardiac Stimulation
0.17
(0.04 to 0.51)
Mechanical Lead Failure
0.12
(0.01 to 0.42)
Elevated Lead Impedance
0.12
(0.01 to 0.42)
Elevated LV Pacing Threshold
0.06
(0.00 to 0.32)
Electrical Lead Failure
0.06
(0.00 to 0.32)
Cardiac Perforation
0.06
(0.00 to 0.32)
11.Secondary Outcome
Title Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold
Hide Description The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and whom experienced phrenic nerve stimulation or high LV pacing threshold.
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description:
Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Number of Participants Analyzed 97
Measure Type: Count of Participants
Unit of Measure: Participants
73
  75.3%
Time Frame Though study exit or study termination, an average of 1.2 years, and up to 4 years
Adverse Event Reporting Description

According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected.

Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.

 
Arm/Group Title Sentus QP Left Ventricular Lead
Hide Arm/Group Description Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
All-Cause Mortality
Sentus QP Left Ventricular Lead
Affected / at Risk (%)
Total   217/2226 (9.75%)    
Hide Serious Adverse Events
Sentus QP Left Ventricular Lead
Affected / at Risk (%) # Events
Total   290/2226 (13.03%)    
Cardiac disorders   
Cardiac perforation associated with the RA lead   1/2226 (0.04%)  1
Cardiac perforation associated with the RV lead   3/2226 (0.13%)  3
Cardiac perforation associated with the LV lead   1/2226 (0.04%)  1
Inability to place LV lead   4/2226 (0.18%)  4
RA lead related lead dislodgement   31/2226 (1.39%)  31
RV lead related lead dislodgement   22/2226 (0.99%)  23
RV lead related elevated pacing threshold   3/2226 (0.13%)  3
RV lead impedance out of range, high impedance   3/2226 (0.13%)  3
RV lead related clinical failure   3/2226 (0.13%)  3
RV lead related mechanical failure   2/2226 (0.09%)  2
RV lead undersensing or loss of sensing   1/2226 (0.04%)  1
Endocarditis associated with the RV lead   1/2226 (0.04%)  1
LV lead related lead dislodgement   59/2226 (2.65%)  66
LV lead related extracardiac stimulation   11/2226 (0.49%)  11
LV lead related mechanical failure   3/2226 (0.13%)  3
LV lead related high pacing threshold   2/2226 (0.09%)  2
LV lead related elevated pacing threshold   2/2226 (0.09%)  2
LV lead related clinical failure   1/2226 (0.04%)  1
LV lead related loss of capture   1/2226 (0.04%)  1
ICD device migration   4/2226 (0.18%)  4
ICD device related inappropriate shock or ATP   8/2226 (0.36%)  8
ICD device related electronic failure   1/2226 (0.04%)  1
RA lead elevated pacing threshold   1/2226 (0.04%)  1
LV lead electrical lead failure   1/2226 (0.04%)  1
LV lead impedance out of range, high   1/2226 (0.04%)  1
General disorders   
Twiddler's syndrome   6/2226 (0.27%)  6
Infections and infestations   
Implant procedure related infection   23/2226 (1.03%)  24
Secondary infection   10/2226 (0.45%)  10
Pocket infection   6/2226 (0.27%)  6
Surgical and medical procedures   
Cardiac perforation   3/2226 (0.13%)  4
Arrhythmia associated with implant procedure   7/2226 (0.31%)  7
Hematoma   17/2226 (0.76%)  17
Loose set-screw   1/2226 (0.04%)  1
Pneumothorax   16/2226 (0.72%)  16
Pericarditis   1/2226 (0.04%)  1
Pleural effusion   4/2226 (0.18%)  4
Pericardial effusion   2/2226 (0.09%)  2
Respiratory arrest   1/2226 (0.04%)  1
Stroke   1/2226 (0.04%)  1
Cardiogenic shock   1/2226 (0.04%)  1
Respiratory distress   3/2226 (0.13%)  3
Renal failure   1/2226 (0.04%)  1
Wound healing disturbance   3/2226 (0.13%)  3
Venous occlusion   3/2226 (0.13%)  3
Discomfort/pain   1/2226 (0.04%)  1
Post surgical bleeding   5/2226 (0.22%)  5
Post procedure anemia   2/2226 (0.09%)  2
Allergy to contrast agent   1/2226 (0.04%)  1
Elevated WBD and labs post procedure   1/2226 (0.04%)  1
Inflammation and swelling at surgical site   1/2226 (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%
Sentus QP Left Ventricular Lead
Affected / at Risk (%) # Events
Total   711/2226 (31.94%)    
Cardiac disorders   
Inability to place LV lead   101/2226 (4.54%)  101
RA lead related lead dislodgement   7/2226 (0.31%)  7
RA lead related undersensing   3/2226 (0.13%)  3
RV lead related clinical failure   2/2226 (0.09%)  2
RV lead related extracardiac stimulation   1/2226 (0.04%)  1
RV lead related high pacing threshold   1/2226 (0.04%)  1
RV lead related oversensing   1/2226 (0.04%)  1
LV lead related extracardiac stimulation   258/2226 (11.59%)  316
LV lead related elevated pacing threshold   132/2226 (5.93%)  147
LV lead related lead dislodgement   27/2226 (1.21%)  29
LV lead related loss of capture   24/2226 (1.08%)  26
LV lead impedance out of range, high impedance   19/2226 (0.85%)  20
LV lead related high pacing threshold   38/2226 (1.71%)  40
LV lead related clinical failure   7/2226 (0.31%)  7
LV lead related oversensing   4/2226 (0.18%)  4
LV lead related mechanical failure   2/2226 (0.09%)  2
LV lead related electrical failure   1/2226 (0.04%)  1
LV lead related loss of sensing   1/2226 (0.04%)  1
ICD device migration   1/2226 (0.04%)  1
ICD device related inappropriate shock or ATP   6/2226 (0.27%)  6
ICD device related housing defect   1/2226 (0.04%)  1
ICD device related high defibrillator (DFT) testing   3/2226 (0.13%)  3
ICD device related pacemaker mediated tachycardia (PMT)   2/2226 (0.09%)  2
RA lead elevated pacing threshold   3/2226 (0.13%)  4
RA lead related extracardiac stimulation   2/2226 (0.09%)  3
RA lead related thrombosis   1/2226 (0.04%)  1
General disorders   
Twiddler's syndrome   3/2226 (0.13%)  3
Rachet syndrome   1/2226 (0.04%)  1
Infections and infestations   
Implant procedure related infection   8/2226 (0.36%)  8
Surgical and medical procedures   
Arrhythmia associated with implant procedure   5/2226 (0.22%)  5
Hematoma   12/2226 (0.54%)  13
Coronary sinus dissection   9/2226 (0.40%)  10
Loose set-screw   1/2226 (0.04%)  1
Pneumothorax   3/2226 (0.13%)  3
Pericardial effusion   4/2226 (0.18%)  4
Pleural effusion   4/2226 (0.18%)  4
Bleeding at surgical site   7/2226 (0.31%)  7
Allergy to surgery prep   6/2226 (0.27%)  6
Unsuccessful defibrillator threshold (DFT) testing   1/2226 (0.04%)  1
Wound healing disturbance   5/2226 (0.22%)  5
Venous occlusion   6/2226 (0.27%)  6
Discomfort/pain at surgical site   14/2226 (0.63%)  14
Pain in shoulder after system revision   1/2226 (0.04%)  1
Hypotension after insertion procedure   2/2226 (0.09%)  2
Bleeding caused by surgical prep   1/2226 (0.04%)  1
Fever after insertion procedure   1/2226 (0.04%)  1
Emesis after insertion procedure   1/2226 (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: Senior Manager, Scientific Affairs
Organization: BIOTRONIK, Inc.
Phone: 1-800-547-0394
EMail: crystal.miller@biotronik.com
Layout table for additonal information
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02290028    
Other Study ID Numbers: CR016
First Submitted: November 10, 2014
First Posted: November 13, 2014
Results First Submitted: January 25, 2021
Results First Posted: March 24, 2021
Last Update Posted: March 24, 2021