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

Medtronic Cardiac Rhythm and Heart Failure1,300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,300

Conditions

Atrial Fibrillation Heart Failure, Congestive

Interventions

Pacemaker Medtronic EnRhythmDEVICE

Pacemaker specific programming

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medtronic Italia S.p.A.

Rome, Italy

Outcomes

Primary Outcomes

Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 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.

Time frame: 2 years

Secondary Outcomes

Death for All Causes at 2 Years

Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years

Time frame: 2 years

Incidence of Permanent Atrial Fibrillation at 2 Years

Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years

Time frame: 2 years

Incidence of Cardiovascular Hospitalizations at 2 Years

Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years

Time frame: 2 years

Burden of Composite Clinical Endpoint

Time frame: 2 years

Subjects' Symptoms

Time frame: 2 years

Heart Failure Medications

Time frame: 2 years

Cumulative Percentage of Ventricular Pacing

Time frame: 2 years

Cardiovascular Death

Time frame: 2 years

Data from ClinicalTrials.gov

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