Optimize RV Selective Site Pacing Clinical Trial

Not Applicable

Terminated

• Conditions: Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial
• Interventions: Device: Medtronic Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

• Registration Number: NCT00422669
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-06-09
• Results First Submitted QC: 2012-10-03
• Results First Posted: 2012-11-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RV Mid-Septal Pacing	Medtronic Dual-Chamber Pacemaker	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
RV Mid-Septal Pacing	Medtronic SelectSecure 3830 Lead	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
RV Apical Pacing	Medtronic Dual-Chamber Pacemaker	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
RV Apical Pacing	Medtronic SelectSecure 3830 Lead	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex

Primary Outcome Measures

Name	Time	Method
The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up	Baseline and 24 months	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.

Secondary Outcome Measures

Name	Time	Method
The Change in LVEF From Two Week Visit to Two Year Follow-up	Baseline and 24 months	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.
The Change in Six-minute Hall Walk Distance	Baseline and 24 months	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.
The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up	Baseline and 24 months	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).
Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up	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 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.
Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up	Baseline and 24 months	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.