Status:
COMPLETED
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome com...
Detailed Description
Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development compared to DDDR pacing in sinus node disfunction patients. Several authors have shown that, in patients with ...
Eligibility Criteria
Inclusion
- Class I/Class II indications for dual chamber pacing
- Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since maximum 2 weeks
- History of atrial arrhythmias (at least one electrocardiogram \[ECG\] or Holter documented episodes in the last 12 months)
Exclusion
- Less than 18 years of age
- Pregnancy
- Unwilling or unable to give informed consent or to commit to follow-up schedule
- Medical conditions that preclude protocol required testing or limit study participation
- Enrolled or intend to participate in another clinical trial during the course of this study
- A life expectancy of less than 2 years
- Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implant
- Anticipated major cardiac surgery within the course of this study
- Permanent III degree AV-block or history of AV node ablation
- History of permanent AF (as defined below)
- AF ablation (left pulmonary veins) or other cardiac surgery \< 3 months
- Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted within two weeks)
- Uncontrolled hyperthyroidism
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT00262119
Start Date
February 1 2006
End Date
April 1 2013
Last Update
July 2 2025
Active Locations (1)
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1
Medtronic Italia S.p.A.
Rome, Italy, 00193