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

Study Overview
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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.

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

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Medtronic Adapta Dual Chamber Pacemaker


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Managed Ventricular Pacing<br>Managed Ventricular Pacing group: programmed on | Device: Medtronic Adapta Dual Chamber Pacemaker<br>* Medtronic Adapta Dual Chamber Pacemaker<br>|
| Active Comparator: Search AV+<br>Search AV+: programmed on | Device: Medtronic Adapta Dual Chamber Pacemaker<br>* Medtronic Adapta Dual Chamber Pacemaker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ |  | 1 month post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Ventricular Pacing |  | 12 months post-implantation | 
| 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 | 
| 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 | 
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB) |  | 1 month post-implantation | 
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB) |  | 1 month post-implantation | 
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB) |  | 1 month post-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Managed Ventricular Pacing