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

February 16, 2006
February 4, 2008
February 2006
Not Provided
Time to first event of cardiovascular hospitalization [ Time Frame: >2 years follow-up ]
Time to first event of death or cardiovascular (CV) hospitalization
Complete list of historical versions of study NCT00293241 on ClinicalTrials.gov Archive Site
  • 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 ]
  •  Demonstrate that fewer patients experience AT/AF with MVP programmed ON compared to patients with MVP OFF and common device programming.
  •  Compare the percentage ventricular pacing in both arms.
  •  Compare the change in, Left Ventricular Ejection Fraction (LVEF) over time in both arms.
  •  Compare the change in NYHA Functional Class over time.
  •  Compare the change in use of Anticoagulation in both arms.
  •  Compare the change in the use of cardiovascular medication over time in both arms.
  •  Compare the incidence of high voltage therapies in both groups.
  •  Compare the hazard rate for all cause mortality in both arms.
  •  Compare the hazard rate for stroke in both arms.
  •  Compare the hazard rate for amount and duration of cardiovascular related hospitalization in both arms.
  •  Evaluate incidence of Class I Pacemaker Indication in ICD patients in both arms.
  •  Compare patient symptoms in both arms.
  •  Compare brain natriuretic peptide (BNP) levels in both arms.
  •  Compare the percentage atrial pacing in both arms.
  •  Evaluate health economics in both arms
Not Provided
Not Provided
 
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
PreFER MVP for Elective Replacement

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cardiovascular Diseases
Device: Feature MVP programmed ON/OFF
Device programming
  • 1
    Managed Ventricular Pacing programmed ON
    Intervention: Device: Feature MVP programmed ON/OFF
  • 2
    Managed Ventricular Pacing programmed off: conventional pacing
    Intervention: Device: Feature MVP programmed ON/OFF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2009
Not Provided

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.
Both
18 Years and older
Yes
Contact: Gwenn EC Wetzels, MSc 0031-43-3566752 gwenn.wetzels@medtronic.com
Contact: Daniel Becker 0031-43-3566716 daniel.becker@medtronic.com
Netherlands
 
NCT00293241
Version 2-Aug 21, 2007
Yes
Not Provided
Medtronic Bakken Research Center
Medtronic
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
Medtronic Bakken Research Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP