Clinical trial NCT01039467: A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
Official title: Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Managed Ventricular Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
timeFrame: 1 month post-implantation
Secondary outcomes:
measure: Percent of Ventricular Pacing
timeFrame: 12 months post-implantation
measure: Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant
timeFrame: 1 month post-implantation
measure: Change in Percent of Ventricular Pacing
timeFrame: from 1 month to 12 months post-implantation
measure: Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
timeFrame: 1 month post-implantation
measure: Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
timeFrame: 1 month post-implantation
measure: Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
timeFrame: 1 month post-implantation
measure: Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
timeFrame: 1 month post-implantation
measure: Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)
timeFrame: 1 month post-implantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: 3rd Hospital of Beijing University
state: Beijing
city: Beijing
country: China
facility: Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Hospital
state: Fujian
city: Guangzhou
country: China
facility: 1st Hospital of Zhongshan Medical University
state: Guangdong
city: Guangzhou
country: China
facility: 2nd Hospital of Zhongshan Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: 1st Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Asian Heart Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Second Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Changchun
country: China
facility: 2nd Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Province People's Hospital
state: Liaoning
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao Medical College
state: Shandong
city: Shanghai
country: China
facility: Shanghai Huadong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Minhang District Hospital
state: Shanghai
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: Xinjiang Automatic District Hospital
state: Xinjiang
city: Kunming
country: China
facility: 1st Hospital of Kunming Medical College
state: Yunnan
city: Kunming
country: China
facility: Yunnan Province 1st People's Hospital
state: Yunnan
city: Yuxi
country: China
facility: Yuxi People's Hospital
state: Yunnan
city: Hangzhou
country: China
facility: 1st Hospital of Medical College, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: 2nd Hospital of Medical College, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai First People's Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shu Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: