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

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Medtronic Adapta Dual Chamber Pacemaker
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring Managed Ventricular Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 3rd Hospital of Beijing University
  • Anzhen Hospital
  • Beijing Hospital
  • Fuwai Hospital
  • Fujian Province Hospital
  • 1st Hospital of Zhongshan Medical University
  • 2nd Hospital of Zhongshan Medical University
  • Guangdong Province People's Hospital
  • 1st Hospital of Zhengzhou University
  • Wuhan Asian Heart Hospital
  • Wuhan Union Hospital
  • Xiangya Second Hospital, Central South University
  • Nanjing Drum Tower Hospital
  • 2nd Hospital of Jilin University
  • Liaoning Province People's Hospital
  • Affiliated Hospital of Qingdao Medical College
  • Shanghai Huadong Hospital
  • Shanghai Minhang District Hospital
  • General Hospital of Tianjin Medical University
  • Tianjin Chest Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • Xinjiang Automatic District Hospital
  • 1st Hospital of Kunming Medical College
  • Yunnan Province 1st People's Hospital
  • Yuxi People's Hospital
  • 1st Hospital of Medical College, Zhejiang University
  • 2nd Hospital of Medical College, Zhejiang University
  • Hangzhou First People's Hospital
  • Zhejiang Hospital
  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Managed Ventricular Pacing

Search AV+

Arm Description

Managed Ventricular Pacing group: programmed on

Search AV+: programmed on

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent of Ventricular Pacing
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.
Change in Percent of Ventricular Pacing
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)

Full Information

First Posted
December 23, 2009
Last Updated
January 23, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01039467
Brief Title
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
Acronym
COMPARE
Official Title
Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Managed Ventricular Pacing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Managed Ventricular Pacing
Arm Type
Active Comparator
Arm Description
Managed Ventricular Pacing group: programmed on
Arm Title
Search AV+
Arm Type
Active Comparator
Arm Description
Search AV+: programmed on
Intervention Type
Device
Intervention Name(s)
Medtronic Adapta Dual Chamber Pacemaker
Intervention Description
Medtronic Adapta Dual Chamber Pacemaker
Primary Outcome Measure Information:
Title
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
Time Frame
1 month post-implantation
Secondary Outcome Measure Information:
Title
Percent of Ventricular Pacing
Time Frame
12 months post-implantation
Title
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant
Description
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.
Time Frame
1 month post-implantation
Title
Change in Percent of Ventricular Pacing
Time Frame
from 1 month to 12 months post-implantation
Title
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
Time Frame
1 month post-implantation
Title
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
Time Frame
1 month post-implantation
Title
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
Time Frame
1 month post-implantation
Title
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
Time Frame
1 month post-implantation
Title
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)
Time Frame
1 month post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Zhang, PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Hospital of Beijing University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Anzhen Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Province Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
1st Hospital of Zhongshan Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
2nd Hospital of Zhongshan Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangdong Province People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
1st Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Wuhan Asian Heart Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Second Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
2nd Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Province People's Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Affiliated Hospital of Qingdao Medical College
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Shanghai Huadong Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Minhang District Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Facility Name
Xinjiang Automatic District Hospital
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
1st Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Yunnan Province 1st People's Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Yuxi People's Hospital
City
Yuxi
State/Province
Yunnan
Country
China
Facility Name
1st Hospital of Medical College, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
2nd Hospital of Medical College, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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