Trial Outcomes & Findings for Optimize RV Follow-up Selective Site Pacing Clinical Trial (NCT NCT00949715)
NCT ID: NCT00949715
Last Updated: 2018-02-15
Results Overview
Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
24 months
Results posted on
2018-02-15
Participant Flow
Study was open to subjects that were previously enrolled in the original randomized Optimize RV Selective Site Pacing Clnical Trial (ORV)(NCT00422669) who consented between October 2009 through April 2011
Two of 67 subjects were excluded due to non-compliant programming.
Participant milestones
| Measure |
RV Apical Pacing
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
RV Apical Pacing
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Missing 24 month LVEF measurement
|
2
|
0
|
Baseline Characteristics
Optimize RV Follow-up Selective Site Pacing Clinical Trial
Baseline characteristics by cohort
| Measure |
RV Apical Pacing
n=32 Participants
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
n=33 Participants
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
73.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
74.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Subjects who had LVEF measurements from both baseline and 24 month timepoints
Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view
Outcome measures
| Measure |
RV Apical Pacing
n=28 Participants
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
n=33 Participants
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month
|
48.3 percentage of LVEF
Interval 43.7 to 53.0
|
51.2 percentage of LVEF
Interval 46.5 to 56.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement
Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.
Outcome measures
| Measure |
RV Apical Pacing
n=28 Participants
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
n=29 Participants
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.
|
-13.5 percentage of LVEF
Interval -17.7 to -9.2
|
-14.6 percentage of LVEF
Interval -19.7 to -9.4
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points
Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.
Outcome measures
| Measure |
RV Apical Pacing
n=28 Participants
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
n=33 Participants
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.
|
55.0 mL
Interval 43.7 to 66.4
|
43.7 mL
Interval 35.0 to 52.4
|
SECONDARY outcome
Timeframe: Whole time from baseline to 24 months averaged by dayPopulation: All subjects who meet inclusion/exclusion criteria for the study.
Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.
Outcome measures
| Measure |
RV Apical Pacing
n=32 Participants
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
RV Mid-Septal Pacing
n=33 Participants
Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
|
|---|---|---|
|
Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.
|
59.2 minutes per day
Standard Deviation 235.3
|
49.3 minutes per day
Standard Deviation 199.5
|
Adverse Events
No Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60