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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014