PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Medtronic

Status and phase

Completed

Phase 4

Conditions

Cardiovascular Diseases

Treatments

Device: Managed Ventricular Pacing programmed ON/OFF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00293241

Version 2-Aug 21, 2007

Details and patient eligibility

About

The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.

Full description

A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.

Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.

MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.

The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.

Enrollment

630 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [VDD]) for a minimum time duration of 2 years
Planned to be replaced or replaced with a device including the MVP feature
Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion
Have signed the informed consent
Have no need to change the pacing mode or the atrioventricular (AV) intervals.

Exclusion criteria

Patients with a cardiac resynchronization therapy (CRT) indication
Permanent AF
Permanent AV block
Inability to complete follow-up visits at a study center.
Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
Planned cardiovascular intervention
Inclusion in another clinical trial that will affect the objectives of this study
Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.