MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

Phase 4

Completed

• Conditions: Atrial Fibrillation; Heart Failure, Congestive
• Interventions: Device: Pacemaker Medtronic EnRhythm

• Registration Number: NCT00262119
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.

Detailed Description

Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development compared to DDDR pacing in sinus node disfunction patients.

Several authors have shown that, in patients with intact AV conduction, unnecessary chronic RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and congestive heart failure. These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects.

The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV conduction.

Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent AF, cardiovascular hospitalizations.

Study Timeline

• Study First Submitted: 2005-12-04
• Study First Submitted QC: 2005-12-04
• Study First Posted: 2005-12-06
• Study Start: 2006-02
• Primary Completion: 2012-04
• Study Completion: 2013-04
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2014-05-09
• Results First Posted: 2014-06-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• Class I/Class II indications for dual chamber pacing
• Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since maximum 2 weeks
• History of atrial arrhythmias (at least one electrocardiogram [ECG] or Holter documented episodes in the last 12 months)

Exclusion Criteria

• Less than 18 years of age
• Pregnancy
• Unwilling or unable to give informed consent or to commit to follow-up schedule
• Medical conditions that preclude protocol required testing or limit study participation
• Enrolled or intend to participate in another clinical trial during the course of this study
• A life expectancy of less than 2 years
• Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implant
• Anticipated major cardiac surgery within the course of this study
• Permanent III degree AV-block or history of AV node ablation
• History of permanent AF (as defined below)
• AF ablation (left pulmonary veins) or other cardiac surgery < 3 months
• Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted within two weeks)
• Uncontrolled hyperthyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVP Only	Pacemaker Medtronic EnRhythm	PM programming according to actual clinical practice + MVP algorithm ON
DDDRP	Pacemaker Medtronic EnRhythm	PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Control Group	Pacemaker Medtronic EnRhythm	PM programming according to actual clinical practice

Primary Outcome Measures

Name	Time	Method
Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years	2 years	The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.

Secondary Outcome Measures

Name	Time	Method
Incidence of Permanent Atrial Fibrillation at 2 Years	2 years	Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years
Burden of Composite Clinical Endpoint	2 years
Cardiovascular Death	2 years
Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay	2 years
Subjects' Symptoms	2 years
Heart Failure Medications	2 years
Any Hospitalization	2 years
Adverse Events	2 years
Development of Atrioventricular (AV) Block and Pacemaker Dependency	2 years
Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism	2 years
Incidence of Cardiovascular Hospitalizations at 2 Years	2 years	Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years
Persistent Atrial Fibrillation (AF)	2 years
Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation	2 years
Death for All Causes at 2 Years	2 years	Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years
Cumulative Percentage of Ventricular Pacing	2 years
Atrial Fibrillation Burden	2 years
Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients	2 years
Frequency, Type, and Associated Cost of Health Care Utilization and Utility	2 years

Trial Locations

Locations (1)

Medtronic Italia S.p.A.; 🇮🇹 Rome, Italy