Optimize RV Selective Site Pacing Clinical Trial

Medtronic

Status: Terminated

Conditions: Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial

Treatments: Device: Medtronic Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422669

604

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

205 participants in 2 patient groups

RV Mid-Septal Pacing

Active Comparator group

Description:

Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart

Treatment:

Device: Medtronic Dual-Chamber Pacemaker

Device: Medtronic SelectSecure 3830 Lead

RV Apical Pacing

Active Comparator group

Description:

Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex

Treatment:

Device: Medtronic Dual-Chamber Pacemaker

Device: Medtronic SelectSecure 3830 Lead