Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV Mid-Septal Pacing | Active Comparator | Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart |
|
| RV Apical Pacing | Active Comparator | Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic or Vitatron Dual-Chamber Pacemaker | Device | A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Optimize RV Follow-Up Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Des Moines | Iowa | United States | ||||
Two of 67 subjects were excluded due to non-compliant programming.
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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Medtronic SelectSecure 3830 Lead | Device | 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. | Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group. | 24 months |
| 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. | Whole time from baseline to 24 months averaged by day |
| Silver Spring |
| Maryland |
| United States |
| Southfield | Michigan | United States |
| Saint Paul | Minnesota | United States |
| New York | New York | United States |
| Cleveland | Ohio | United States |
| Nashville | Tennessee | United States |
| Fort Worth | Texas | United States |
| Tomball | Texas | United States |
| Burlington | Vermont | United States |
| Ramat Gan | Israel |
| Rovigo | Italy |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Subjects who had LVEF measurements from both baseline and 24 month timepoints | Posted | Mean | 95% Confidence Interval | percentage of LVEF | 24 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement | Posted | Mean | 95% Confidence Interval | percentage of LVEF | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points | Posted | Mean | 95% Confidence Interval | mL | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All subjects who meet inclusion/exclusion criteria for the study. | Posted | Mean | Standard Deviation | minutes per day | Whole time from baseline to 24 months averaged by day |
|
Not provided
The collection of adverse events and subject deaths was not required to meet the objectives of this study and thus was not performed. The products are market approved and used within labeling. Any alleged device related deaths, serious injury, compliants, event would be reported not to this study but via Medical Device Reporting.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Subjects | No subjects had adverse events or death collected as part of this study. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Since the enrollment goal of the study (n=160) was not met (it was decided to stop enrollments after 67 due to slow enrollments), the results of the study were not powered and the results for the primary objective are inconclusive at this time.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Rose | Medtronic CRDM | 763-526-2332 | rachael.k.rose@medtronic.com |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|