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

NCT ID: NCT01039467

Last Updated: 2020-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Managed Ventricular Pacing

Managed Ventricular Pacing group: programmed on

Group Type ACTIVE_COMPARATOR

Medtronic Adapta Dual Chamber Pacemaker

Intervention Type DEVICE

Medtronic Adapta Dual Chamber Pacemaker

Search AV+

Search AV+: programmed on

Group Type ACTIVE_COMPARATOR

Medtronic Adapta Dual Chamber Pacemaker

Intervention Type DEVICE

Medtronic Adapta Dual Chamber Pacemaker

Interventions

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Medtronic Adapta Dual Chamber Pacemaker

Medtronic Adapta Dual Chamber Pacemaker

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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3rd Hospital of Beijing University

Beijing, Beijing Municipality, China

Site Status

Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Province Hospital

Fuzhou, Fujian, China

Site Status

1st Hospital of Zhongshan Medical University

Guangzhou, Guangdong, China

Site Status

2nd Hospital of Zhongshan Medical University

Guangzhou, Guangdong, China

Site Status

Guangdong Province People's Hospital

Guangzhou, Guangdong, China

Site Status

1st Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Wuhan Asian Heart Hospital

Wuhan, Hubei, China

Site Status

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status

Xiangya Second Hospital, Central South University

Changsha, Hunan, China

Site Status

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

2nd Hospital of Jilin University

Changchun, Jilin, China

Site Status

Liaoning Province People's Hospital

Shenyang, Liaoning, China

Site Status

Affiliated Hospital of Qingdao Medical College

Qingdao, Shandong, China

Site Status

Shanghai Huadong Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Minhang District Hospital

Shanghai, Shanghai Municipality, China

Site Status

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Xinjiang Automatic District Hospital

Ürümqi, Xinjiang, China

Site Status

1st Hospital of Kunming Medical College

Kunming, Yunnan, China

Site Status

Yunnan Province 1st People's Hospital

Kunming, Yunnan, China

Site Status

Yuxi People's Hospital

Yuxi, Yunnan, China

Site Status

1st Hospital of Medical College, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

2nd Hospital of Medical College, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Hospital

Hangzhou, Zhejiang, China

Site Status

Shanghai First People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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COMPARE Study

Identifier Type: -

Identifier Source: org_study_id

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