A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing (COMPARE)

Medtronic

Status

Completed

Conditions

Bradycardia

Treatments

Device: Medtronic Adapta Dual Chamber Pacemaker

Study type

Interventional

Funder types

Industry

Identifiers

NCT01039467

COMPARE Study

Details and patient eligibility

About

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.

Full description

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.

Enrollment

385 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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