Trial Outcomes & Findings for Quadripolar CRT-D On Currently Approved Lead SystemS (NCT NCT02232984)
NCT ID: NCT02232984
Last Updated: 2019-04-09
Results Overview
The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
Recruitment status
COMPLETED
Target enrollment
749 participants
Primary outcome timeframe
Pre-discharge (up to 7 days post implant)
Results posted on
2019-04-09
Participant Flow
A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.
Participant milestones
| Measure |
All Study Patients
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
|---|---|
|
Overall Study
STARTED
|
749
|
|
Overall Study
Successfully Implanted
|
675
|
|
Overall Study
COMPLETED
|
672
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
All Study Patients
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
1
|
|
Overall Study
Investigator withdrawal
|
10
|
|
Overall Study
Device implant unsuccessful
|
53
|
|
Overall Study
not disclosed by site
|
7
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Patients
n=742 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 10.3 • n=742 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=742 Participants
|
|
Sex: Female, Male
Male
|
562 Participants
n=742 Participants
|
|
Region of Enrollment
United States
|
742 Participants
n=742 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) %
|
26.5 %
STANDARD_DEVIATION 8.3 • n=738 Participants • Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients.
|
|
QRS width
|
153.7 ms
STANDARD_DEVIATION 28.6 • n=736 Participants • Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients.
|
PRIMARY outcome
Timeframe: Pre-discharge (up to 7 days post implant)The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
Outcome measures
| Measure |
All Study Patients
n=672 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
Other LV Lead Delivery Systems
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
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|---|---|---|
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Number of Vectors With Phrenic Nerve Stimulation (PNS)
Unique pacing vectors with PNS
|
181 Number of Pacing vectors with PNS
|
—
|
|
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Common vectors with PNS
|
189 Number of Pacing vectors with PNS
|
—
|
SECONDARY outcome
Timeframe: Pre-discharge (up to 7 days post implant)Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Outcome measures
| Measure |
All Study Patients
n=672 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
Other LV Lead Delivery Systems
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
|
|---|---|---|
|
Final Pacing Treshold at Pre-discharge
|
1.93 Volts
Standard Deviation 1.87
|
—
|
SECONDARY outcome
Timeframe: Pre-discharge (up to 7 days post implant)Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Outcome measures
| Measure |
All Study Patients
n=672 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
Other LV Lead Delivery Systems
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
|
|---|---|---|
|
Final LV Lead Impedance at Pre-discharge
|
1034.7 Ohms
Standard Deviation 310.6
|
—
|
SECONDARY outcome
Timeframe: Pre-discharge (up to 7 days post implant)Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Outcome measures
| Measure |
All Study Patients
n=672 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
Other LV Lead Delivery Systems
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
|
|---|---|---|
|
Final Sensing Amplitude at Pre-discharge
|
13.30 Milivolts
Standard Deviation 6.40
|
—
|
SECONDARY outcome
Timeframe: At time of implantation (0 to 30 days post consent signature)Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.
Outcome measures
| Measure |
All Study Patients
n=394 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
|
Other LV Lead Delivery Systems
n=281 Participants
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
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|---|---|---|
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Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
Skin to skin time (min)
|
82.4 Minutes
Standard Deviation 38.9
|
87.8 Minutes
Standard Deviation 38.9
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|
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
Lead placement time (min)
|
24.5 Minutes
Standard Deviation 23.5
|
29.8 Minutes
Standard Deviation 24.8
|
|
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
CS Canulation Time (min)
|
6.2 Minutes
Standard Deviation 9.4
|
7.8 Minutes
Standard Deviation 12.2
|
|
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
Overall catheter in the body time (min)
|
25.9 Minutes
Standard Deviation 21.8
|
32.7 Minutes
Standard Deviation 25.1
|
Adverse Events
All Study Patients
Serious events: 16 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Study Patients
n=749 participants at risk
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance.
|
|---|---|
|
Injury, poisoning and procedural complications
Adverse reaction - general
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Injury, poisoning and procedural complications
Adverse drug reaction - respiratory
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Inadvertent VT/VF
|
0.27%
2/749 • Number of events 2 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Injury, poisoning and procedural complications
Hematoma pocket <= 30 days
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Dislodgement - undersensing RV
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Dislodgement - no reported signs - RA
|
0.53%
4/749 • Number of events 4 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Elevated threshold - RV
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Dislodgment - no reported signs - LV
|
0.40%
3/749 • Number of events 3 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Injury, poisoning and procedural complications
Coronary venous dissection
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Cardiac disorders
Dislodgment - no reported signs - RV
|
0.13%
1/749 • Number of events 1 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
Other adverse events
| Measure |
All Study Patients
n=749 participants at risk
All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance.
|
|---|---|
|
Cardiac disorders
Dislodgement - no reported signs - RA
|
0.67%
5/749 • Number of events 5 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
|
Injury, poisoning and procedural complications
Coronary Venous dissection
|
0.80%
6/749 • Number of events 6 • From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place