MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Atrial Fibrillation, Heart Failure, Congestive
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Physiological pacing, Antitachycardia pacing therapies
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Medtronic Italia S.p.A.
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Control Group
MVP Only
DDDRP
PM programming according to actual clinical practice
PM programming according to actual clinical practice + MVP algorithm ON
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON