MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00262119
First received: December 4, 2005
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Heart Failure, Congestive
Device: Pacemaker Medtronic EnRhythm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.


Secondary Outcome Measures:
  • Death for All Causes at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years

  • Incidence of Permanent Atrial Fibrillation at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years

  • Incidence of Cardiovascular Hospitalizations at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years

  • Burden of Composite Clinical Endpoint [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Subjects' Symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Heart Failure Medications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cumulative Percentage of Ventricular Pacing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cardiovascular Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Any Hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Atrial Fibrillation Burden [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Persistent Atrial Fibrillation (AF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Development of Atrioventricular (AV) Block and Pacemaker Dependency [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency, Type, and Associated Cost of Health Care Utilization and Utility [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1300
Study Start Date: February 2006
Study Completion Date: April 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
PM programming according to actual clinical practice
Device: Pacemaker Medtronic EnRhythm
Pacemaker specific programming
Active Comparator: MVP Only
PM programming according to actual clinical practice + MVP algorithm ON
Device: Pacemaker Medtronic EnRhythm
Pacemaker specific programming
Active Comparator: DDDRP
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Device: Pacemaker Medtronic EnRhythm
Pacemaker specific programming

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 intact AV conduction, unnecessary chronic RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and congestive heart failure. These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects.

The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV conduction.

Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent AF, cardiovascular hospitalizations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262119

Locations
Italy
Medtronic Italia S.p.A.
Rome, Italy, 00193
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Luigi Padeletti, Prof. Ospedale Careggi - Firenze
Principal Investigator: Giuseppe Boriani, Dr. Ospedale Sant'Orsola - Bologna
Principal Investigator: Luis Mont, Dr. Hospital Clinic of Barcelona
Principal Investigator: Reinhard C Funck, Dr. Philipps University Hospital - Marburg
Principal Investigator: Carsten W Israel, Dr. J. W. Goethe University Hospital - Frankfurt
Principal Investigator: Helmut Pürerfellner, Dr. Elisabethinen Hospital Linz
Principal Investigator: Antonis S Manolis, Prof. Evagelismos Hospital - Athens
Principal Investigator: André Pisapia, Dr Hôpital Saint-Joseph - Marseille
Principal Investigator: Raymond Tukkie, Dr Kennemer Gasthuis
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00262119     History of Changes
Other Study ID Numbers: MNV-20-171005
Study First Received: December 4, 2005
Results First Received: May 9, 2014
Last Updated: May 9, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
Physiological pacing
Antitachycardia pacing therapies

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014