Optimize RV Follow-up Selective Site Pacing Clinical Trial

Not Applicable

Completed

• Conditions: Cardiac Pacing; Right Ventricular Pacing; Left Ventricular Ejection Fraction
• Interventions: Device: Medtronic or Vitatron Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

• Registration Number: NCT00949715
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Timeline

• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-30
• Study Start: 2009-09
• Primary Completion: 2011-04
• Study Completion: 2011-12
• Results First Submitted: 2013-03-11
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-10-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RV Mid-Septal Pacing	Medtronic SelectSecure 3830 Lead	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	Medtronic SelectSecure 3830 Lead	Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
RV Mid-Septal Pacing	Medtronic or Vitatron Dual-Chamber Pacemaker	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	Medtronic or Vitatron Dual-Chamber Pacemaker	Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.