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

Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

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.

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