Optimize RV Selective Site Pacing Clinical Trial

Medtronic Cardiac Rhythm and Heart Failure205 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

205

Conditions

Cardiac Pacing, Artificial Cardiac Pacemaker, Artificial

Interventions

Medtronic Dual-Chamber PacemakerDEVICE

A Medtronic market-approved dual-chamber implantable pulse generator (IPG)

Medtronic SelectSecure 3830 LeadDEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Unnamed facility

Bridgeport, Connecticut, United States

Unnamed facility

Clearwater, Florida, United States

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 24 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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