Optimize RV Follow-up Selective Site Pacing Clinical Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

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