Phase 4
N=1,166
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Atrial Fibrillation · Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00262119 ↗Enrolled (actual)
1,166
Serious AEs
44.1%
Results posted
Jun 2014
Primary outcome: Primary: Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years — 28.0; 23.1; 21.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pacemaker Medtronic EnRhythm (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years |
28.0; 23.1; 21.5 | — |
| SECONDARY Death for All Causes at 2 Years |
5.6; 5.1; 4.6 | — |
| SECONDARY Incidence of Permanent Atrial Fibrillation at 2 Years |
9.2; 7.7; 3.8 | — |
| SECONDARY Incidence of Cardiovascular Hospitalizations at 2 Years |
16.8; 13.7; 15.2 | — |
| SECONDARY Burden of Composite Clinical Endpoint |
— | — |
| SECONDARY Subjects' Symptoms |
— | — |
| SECONDARY Heart Failure Medications |
— | — |
| SECONDARY Cumulative Percentage of Ventricular Pacing |
— | — |
| SECONDARY Cardiovascular Death |
— | — |
| SECONDARY Any Hospitalization |
— | — |
| SECONDARY Atrial Fibrillation Burden |
— | — |
| SECONDARY Persistent Atrial Fibrillation (AF) |
— | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Development of Atrioventricular (AV) Block and Pacemaker Dependency |
— | — |
| SECONDARY Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism |
— | — |
| SECONDARY Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation |
— | — |
| SECONDARY Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay |
— | — |
| SECONDARY Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients |
— | — |
| SECONDARY Frequency, Type, and Associated Cost of Health Care Utilization and Utility |
— | — |
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 composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.
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
Data sourced from ClinicalTrials.gov (NCT00262119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.