Optimize RV Selective Site Pacing Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the Optimize RV 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 select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.

Official Title
-----------------
Optimize RV Selective Site Pacing Clinical Trial

Conditions
-----------------
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial

Intervention / Treatment
-----------------
* Device: Medtronic Dual-Chamber Pacemaker
* Device: Medtronic SelectSecure 3830 Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment Subjects greater than 18 yrs of age Subjects that are indicated for a dual chamber pacemaker Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle Exclusion Criteria: Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines) Subjects indicated for an implantable cardiac defibrillator (ICD) Subjects with permanent atrial fibrillation (AF) Subjects with expected managed ventricular pacing turned on Subjects with a previously implanted pacemaker, ICD, or CRT device Subjects with an myocardial infarction (MI) within 3 months prior to enrollment Subjects that received bypass surgery within 3 months prior to enrollment Subjects that had valve replacement within 3 months prior to enrollment Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease Subjects with a mechanical right heart valve Women who are pregnant or nursing Significant co-morbidity preventing study completion Terminal conditions with a life expectancy of less than two years Participation in another study that would confound the results of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RV Mid-Septal Pacing<br>Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart | Device: Medtronic Dual-Chamber Pacemaker<br>* A Medtronic market-approved dual-chamber implantable pulse generator (IPG)<br>Device: Medtronic SelectSecure 3830 Lead<br>* Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead<br>|
| Active Comparator: RV Apical Pacing<br>Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex | Device: Medtronic Dual-Chamber Pacemaker<br>* A Medtronic market-approved dual-chamber implantable pulse generator (IPG)<br>Device: Medtronic SelectSecure 3830 Lead<br>* Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. | Baseline and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in LVEF From Two Week Visit to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. | Baseline and 24 months | 
| The Change in Six-minute Hall Walk Distance | The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance. | Baseline and 24 months | 
| The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up | LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume). | Baseline and 24 months | 
| Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up | Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate. | Baseline and 24 months | 
| Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up | Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate. | Baseline and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Select Site Pacing