Cardiac Pacing, Left Ventricular Ejection Fraction, Right Ventricular Pacing
Conditions
Keywords
Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Selective Site Pacing
Brief summary
The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of selective site pacing is to improve how the heart contracts when paced.
Detailed description
The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.
Interventions
DEVICEMedtronic 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 market-approved SelectSecure Model 3830 bipolar pacing lead
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007) * Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)
Exclusion criteria
* Subjects who have a device that was programmed outside the Optimize RV programming requirements * Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device * Subjects who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month | 24 months | Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 months | 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. |
| Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group. | 24 months | Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group. |
| Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups. | Whole time from baseline to 24 months averaged by day | 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. |
Countries
Israel, Italy, United States
Participant flow
Recruitment details
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
Pre-assignment details
Two of 67 subjects were excluded due to non-compliant programming.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| 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 | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Missing 24 month LVEF measurement | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | RV Mid-Septal Pacing | Total | RV Apical Pacing |
|---|---|---|---|
| Age, Continuous | 73.3 years STANDARD_DEVIATION 10.6 | 74.4 years STANDARD_DEVIATION 9.3 | 75.6 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 59 Participants | 29 Participants |
| Sex: Female, Male Female | 20 Participants | 45 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month
Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view
Time frame: 24 months
Population: Subjects who had LVEF measurements from both baseline and 24 month timepoints
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RV Apical Pacing | Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month | 48.3 percentage of LVEF |
| RV Mid-Septal Pacing | Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month | 51.2 percentage of LVEF |
Comparison: HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.p-value: 0.235295% CI: [-2.7, 10.8]t-test, 2 sided
Secondary
Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.
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.
Time frame: Whole time from baseline to 24 months averaged by day
Population: All subjects who meet inclusion/exclusion criteria for the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RV Apical Pacing | 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 |
| RV Mid-Septal Pacing | Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups. | 49.3 minutes per day | Standard Deviation 199.5 |
Comparison: Ho: The AT/AF burden in the RVS group is the same as the RVA group.p-value: 0.9835Wilcoxon (Mann-Whitney)
Secondary
Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.
Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.
Time frame: 24 months
Population: All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RV Apical Pacing | Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group. | 55.0 mL |
| RV Mid-Septal Pacing | Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group. | 43.7 mL |
Comparison: Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volumep-value: 0.105195% CI: [-25.1, 2.4]t-test, 2 sided
Secondary
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.
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.
Time frame: 24 months
Population: Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RV Apical Pacing | 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 |
| RV Mid-Septal Pacing | 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. | -14.6 percentage of LVEF |
Comparison: Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.p-value: 0.740595% CI: [-7.6, 5.5]t-test, 2 sided