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

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai First People's Hospital
  • Beijing
    • Beijing, Beijing, China
      • Fuwai Hospital
    • Beijing, Beijing, China
      • Beijing Hospital
    • Beijing, Beijing, China
      • 3rd Hospital of Beijing University
    • Beijing, Beijing, China
      • Anzhen Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Province Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • 1st Hospital of Zhongshan Medical University
    • Guangzhou, Guangdong, China
      • 2nd Hospital of Zhongshan Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Province People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • 1st Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Union Hospital
    • Wuhan, Hubei, China
      • Wuhan Asian Heart Hospital
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Second Hospital, Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Drum Tower Hospital
  • Jilin
    • Changchun, Jilin, China
      • 2nd Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning Province People's Hospital
  • Shandong
    • Qingdao, Shandong, China
      • Affiliated Hospital of Qingdao Medical College
  • Shanghai
    • Shanghai, Shanghai, China
      • ShangHai Huadong Hospital
    • Shanghai, Shanghai, China
      • Shanghai Minhang District Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • General Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China
      • Tianjin Chest Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • First Affiliated Hospital of Xinjiang Medical University
    • Ürümqi, Xinjiang, China
      • Xinjiang Automatic District Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • 1st Hospital of Kunming Medical College
    • Kunming, Yunnan, China
      • Yunnan Province 1st People's Hospital
    • Yuxi, Yunnan, China
      • Yuxi People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China
      • 1st Hospital of Medical College, Zhejiang University
    • Hangzhou, Zhejiang, China
      • 2nd Hospital of Medical College, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Managed Ventricular Pacing; Managed Ventricular Pacing group: programmed on	Device: Medtronic Adapta Dual Chamber Pacemaker; Medtronic Adapta Dual Chamber Pacemaker
ACTIVE_COMPARATOR: Search AV+; Search AV+: programmed on	Device: Medtronic Adapta Dual Chamber Pacemaker; Medtronic Adapta Dual Chamber Pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+	1 month post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Ventricular Pacing		12 months post-implantation
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant	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.	1 month post-implantation
Change in Percent of Ventricular Pacing		from 1 month to 12 months post-implantation
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)		1 month post-implantation
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)		1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)		1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)		1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)		1 month post-implantation

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (ESTIMATE): December 25, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Managed Ventricular Pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: COMPARE Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO