PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Cardiovascular Diseases Clinical Trial

Official title: PreFER MVP for Elective Replacement

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

• NCT number: NCT00293241
• Study type: Interventional
• Source: Medtronic Bakken Research Center
• Status: Completed
• Phase: Phase 4
• Start date: February 2006
• Completion date: August 2011