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Completed

NCT Number: NCT01039467

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

3rd Hospital of Beijing University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Adapta Dual Chamber Pacemaker

Device

Medtronic Adapta Dual Chamber Pacemaker

Primary outcomes

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

    Time frame: 1 month post-implantation

Secondary outcomes

  1. Percent of Ventricular Pacing

    Time frame: 12 months post-implantation

  2. Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant

    Time frame: 1 month post-implantation

    To compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients by measuring the percent burden of atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.

  3. Change in Percent of Ventricular Pacing

    Time frame: from 1 month to 12 months post-implantation

  4. Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)

    Time frame: 1 month post-implantation

  5. Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)

    Time frame: 1 month post-implantation

  6. Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)

    Time frame: 1 month post-implantation

  7. Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)

    Time frame: 1 month post-implantation

  8. Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)

    Time frame: 1 month post-implantation

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Acronym: COMPARE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 25, 2009
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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