NCT00293241

PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

PreFER MVP for Elective Replacement

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Managed Ventricular Pacing programmed ON/OFF	Device programming

Timeline

• Start date: 2006-02-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2006-02-17
• Last updated: 2016-06-24
• Results posted: 2015-06-30

Locations

1 site across 1 country: Netherlands