PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Medtronic Bakken Research Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00293241
First received: February 16, 2006
Last updated: February 4, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Device: Feature MVP programmed ON/OFF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: PreFER MVP for Elective Replacement

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Time to first event of cardiovascular hospitalization [ Time Frame: >2 years follow-up ]

Secondary Outcome Measures:
  • Demonstrate that fewer patients experience atrial tachycardia/atrial fibrillation (AT/AF) with MVP programmed ON compared to patients with MVP OFF and common device programming [ Time Frame: >2 years follow-up ]
  • Compare the percentage ventricular pacing in both arms [ Time Frame: >2 years follow-up ]
  • Compare the change in New York Heart Association (NYHA) functional class over time [ Time Frame: >2 years follow-up ]
  • Compare the change in use of anticoagulation in both arms [ Time Frame: >2 years follow-up ]
  • Compare the change in the use of cardiovascular medication over time in both arms [ Time Frame: >2 years follow-up ]
  • Compare the incidence of high voltage therapies in both groups [ Time Frame: >2 years follow-up ]
  • Compare the hazard rate for all cause mortality in both arms [ Time Frame: >2 years follow-up ]
  • Compare the hazard rate for stroke in both arms [ Time Frame: >2 years follow-up ]
  • Compare the hazard rate for amount and duration of cardiovascular related hospitalization in both arms [ Time Frame: >2 years follow-up ]
  • Evaluate incidence of Class I pacemaker indication in ICD patients in both arms [ Time Frame: >2 years follow-up ]
  • Compare patient symptoms in both arms [ Time Frame: >2 years follow-up ]
  • Compare the percentage atrial pacing in both arms [ Time Frame: >2 years follow-up ]
  • Evaluate health economics in both arms [ Time Frame: >2 years follow-up ]

Estimated Enrollment: 600
Study Start Date: February 2006
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
1
Managed Ventricular Pacing programmed ON
Device: Feature MVP programmed ON/OFF
Device programming
2
Managed Ventricular Pacing programmed off: conventional pacing
Device: Feature MVP programmed ON/OFF
Device programming

Detailed Description:

A number of clinical studies (Danish I1,2, Danish II3,4, David5,27, MOST6) over the past few years have shown that, in patients with intact 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 AAI3, 13 and needs further investigation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293241

Contacts
Contact: Gwenn EC Wetzels, MSc 0031-43-3566752 gwenn.wetzels@medtronic.com
Contact: Daniel Becker 0031-43-3566716 daniel.becker@medtronic.com

Locations
Netherlands
Medtronic Bakken Research Center Recruiting
Maastricht, Netherlands
Contact: Gwenn Wetzels, MSc    0031-43-3566752    gwenn.wetzels@medtronic.com   
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Oliver Piot, Dr. Centre Cardiologique du Nord, Saint-Denis, France
Principal Investigator: Aurelio Quesada, Dr. Hospital General Universitario de Valencia, Spain
Principal Investigator: De Roy, Prof. Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium
Principal Investigator: Renato Ricci, Dr. San Filippo Neri Hospital, Rome, Italy
Principal Investigator: Gianluca Botto, Dr. Como S. Anna Hospital, Como, Italy
Principal Investigator: Milan Kozak, Dr. Fakultní nemocnice Brno Bohunice, Brno, Czech Republic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293241     History of Changes
Other Study ID Numbers: Version 2-Aug 21, 2007
Study First Received: February 16, 2006
Last Updated: February 4, 2008
Health Authority: France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Pacemaker or ICD replacement

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014