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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01039467
First received: December 23, 2009
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Physical Pacing to Reduce Ventricular Pacing
Device: Medtronic Adapta Dual Chamber Pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of an Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Reduction of ventricular pacing [ Time Frame: Baseline to 1 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AF burden defined by Cardiac Compass [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  • Characterization of Adapta patient's clinical profile [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Search AV+
Search AV+ used in dual chamber pacemaker
Device: Medtronic Adapta Dual Chamber Pacemaker
Medtronic Adapta Dual Chamber Pacemaker
Active Comparator: MVP
Managed Ventricular Pacing (MVP) used in dual chamber pacemaker
Device: Medtronic Adapta Dual Chamber Pacemaker
Medtronic Adapta Dual Chamber Pacemaker

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039467

  Show 30 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Shu Zhang, PhD Fuwai Hospital
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01039467     History of Changes
Other Study ID Numbers: COMPARE Study
Study First Received: December 23, 2009
Last Updated: August 20, 2012
Health Authority: China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Managed Ventricular Pacing

ClinicalTrials.gov processed this record on April 15, 2014