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

Bradycardia Clinical Trial

— COMPARE  

Official title:

Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039467
• Other study ID #: COMPARE Study
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Medtronic Adapta Dual Chamber Pacemaker
Medtronic Adapta Dual Chamber Pacemaker

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+		1 month post-implantation
Secondary	Percent of Ventricular Pacing		12 months post-implantation
Secondary	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
Secondary	Change in Percent of Ventricular Pacing		from 1 month to 12 months post-implantation
Secondary	Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)		1 month post-implantation
Secondary	Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)		1 month post-implantation
Secondary	Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)		1 month post-implantation
Secondary	Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)		1 month post-implantation
Secondary	Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)		1 month post-implantation