MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure - Full Text View

Sponsor:	Medtronic Bakken Research Center
Information provided by (Responsible Party):	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00262119

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Death for all causes at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Incidence of permanent atrial fibrillation at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1300
Study Start Date:	February 2006
Estimated Study Completion Date:	April 2012
Estimated 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

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 - 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:

Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91.

Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62.

Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6.

Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.

Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Andersen HR. Incidence of atrial fibrillation and thromboembolism in a randomised trial of atrial versus dual chamber pacing in 177 patients with sick sinus syndrome. Heart. 2004 Jun;90(6):661-6.

Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95.

Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Funck RC, Boriani G, Manolis AS, Püererfellner H, Mont L, Tukkie R, Pisapia A, Israel CW, Grovale N, Grammatico A, Padeletti L; MINERVA Study Group. The MINERVA study design and rationale: a controlled randomized trial to assess the clinical benefit of minimizing ventricular pacing in pacemaker patients with atrial tachyarrhythmias. Am Heart J. 2008 Sep;156(3):445-51.

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
Last Updated:	February 22, 2012
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 May 21, 2012