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
1 other identifier
interventional
385
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 23, 2009
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 5, 2020
January 1, 2020
4.8 years
December 23, 2009
October 10, 2016
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
1 month post-implantation
Secondary Outcomes (8)
Percent of Ventricular Pacing
12 months post-implantation
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant
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
- +3 more secondary outcomes
Study Arms (2)
Managed Ventricular Pacing
ACTIVE COMPARATORManaged Ventricular Pacing group: programmed on
Search AV+
ACTIVE COMPARATORSearch AV+: programmed on
Interventions
Medtronic Adapta Dual Chamber Pacemaker
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
3rd Hospital of Beijing University
Beijing, Beijing Municipality, China
Anzhen Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Fujian Province Hospital
Fuzhou, Fujian, China
1st Hospital of Zhongshan Medical University
Guangzhou, Guangdong, China
2nd Hospital of Zhongshan Medical University
Guangzhou, Guangdong, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, China
1st Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Asian Heart Hospital
Wuhan, Hubei, China
Wuhan Union Hospital
Wuhan, Hubei, China
Xiangya Second Hospital, Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
2nd Hospital of Jilin University
Changchun, Jilin, China
Liaoning Province People's Hospital
Shenyang, Liaoning, China
Affiliated Hospital of Qingdao Medical College
Qingdao, Shandong, China
Shanghai Huadong Hospital
Shanghai, Shanghai Municipality, China
Shanghai Minhang District Hospital
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Xinjiang Automatic District Hospital
Ürümqi, Xinjiang, China
1st Hospital of Kunming Medical College
Kunming, Yunnan, China
Yunnan Province 1st People's Hospital
Kunming, Yunnan, China
Yuxi People's Hospital
Yuxi, Yunnan, China
1st Hospital of Medical College, Zhejiang University
Hangzhou, Zhejiang, China
2nd Hospital of Medical College, Zhejiang University
Hangzhou, Zhejiang, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Shanghai First People's Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shu Zhang
- Organization
- Fuwai Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Shu Zhang, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2009
First Posted
December 25, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 5, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share