Status:
COMPLETED
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00293241
Start Date
February 1 2006
End Date
August 1 2011
Last Update
June 24 2016
Active Locations (1)
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1
Medtronic Bakken Research Center
Maastricht, Netherlands