Phase 4
Completed N=1,166
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Atrial Fibrillation · Heart Failure, Congestive
Source: ClinicalTrials.gov NCT00262119 ↗
Enrolled (actual)
1,166
Serious AEs
44.1%
Results posted
Jun 2014
Primary outcomePrimary: 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
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.
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 |
— | — |
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. Informational only — not medical advice.