A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

Medtronic Cardiac Rhythm and Heart Failure385 enrolled

Overview

The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.

Recent studies suggest that chronic right ventricular pacing is associated with a variety of adverse effects in patients, particularly those with intact or intermittent atrioventricular (AV) conduction. Medtronic Adapta® pacemakers include Managed Ventricular Pacing®, a pacing mode designed to promote intrinsic conduction, and also Search AV™+, a feature designed to reduce unnecessary ventricular pacing in patients with intact or intermittent AV conduction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

385

Conditions

Bradycardia

Interventions

Medtronic Adapta Dual Chamber PacemakerDEVICE

Medtronic Adapta Dual Chamber Pacemaker

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated study informed consent * Class I or Class IIa pacemaker indication * Geographically stable and available for follow-up at the center for the length of the study * Age greater than 18 * To be implanted with Adapta dual chamber pacemaker Exclusion Criteria: * Unwillingness or inability to give written informed consent to participate in the Study * Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device * Life expectancy of less than one year * Patient has a mechanical tricuspid heart valve * Medical conditions that preclude the testing requirement by the protocol or limit study participation * Patient has persistent 3rd degree atrioventricular (AV) block * Patient has persistent atrial fibrillation (AF) * Patient has neurogenic syncope * Patient has carotid sinus syndrome * Patient has hypertrophic obstructive cardiomyopathy * Inclusion in another clinical trial or study

Locations (30)

Outcomes

Primary Outcomes

Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+