N/A N=385 Randomized Prevention

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

Bradycardia

Bottom Line

View on ClinicalTrials.gov: NCT01039467 ↗

Enrolled (actual)

385

Serious AEs

2.3%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ — 1; 4 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Medtronic Adapta Dual Chamber Pacemaker (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+	1; 4	<0.0001 sig
SECONDARY Percent of Ventricular Pacing	0.40; 2.95	<0.0001 sig
SECONDARY Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant	1.40; 0.50	0.833
SECONDARY Change in Percent of Ventricular Pacing	-0.10; 0.00	0.265
SECONDARY Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)	132; 91	<0.0001 sig
SECONDARY Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)	1; 1	<0.0001 sig
SECONDARY Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)	1.50; 21.80	0.0008 sig
SECONDARY Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)	21.40; 80.60	0.053
SECONDARY Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)	79.20; 22.45	0.493

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01039467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.