MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
NCT ID: NCT00262119
Last Updated: 2025-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1300 participants
INTERVENTIONAL
2006-02-28
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control Group
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm
Pacemaker specific programming
MVP Only
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm
Pacemaker specific programming
DDDRP
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm
Pacemaker specific programming
Interventions
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Pacemaker Medtronic EnRhythm
Pacemaker specific programming
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Luigi Padeletti, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Careggi - Firenze
Giuseppe Boriani, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Sant'Orsola - Bologna
Luis Mont, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Reinhard C Funck, Dr.
Role: PRINCIPAL_INVESTIGATOR
Philipps University Hospital - Marburg
Carsten W Israel, Dr.
Role: PRINCIPAL_INVESTIGATOR
J. W. Goethe University Hospital - Frankfurt
Helmut Pürerfellner, Dr.
Role: PRINCIPAL_INVESTIGATOR
Elisabethinen Hospital
Antonis S Manolis, Prof.
Role: PRINCIPAL_INVESTIGATOR
Evagelismos Hospital - Athens
André Pisapia, Dr
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Joseph - Marseille
Raymond Tukkie, Dr
Role: PRINCIPAL_INVESTIGATOR
Kennemer Gasthuis
Locations
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Medtronic Italia S.p.A.
Rome, , Italy
Countries
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References
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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. doi: 10.1056/NEJM200005113421902.
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; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
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. doi: 10.1053/euhj.1997.0616.
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. doi: 10.1016/S0140-6736(97)03425-9.
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. doi: 10.1136/hrt.2003.016063.
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. doi: 10.1161/01.cir.97.10.987.
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. doi: 10.1016/s0735-1097(03)00757-5.
Boriani G, Tukkie R, Manolis AS, Mont L, Purerfellner H, Santini M, Inama G, Serra P, de Sousa J, Botto GL, Mangoni L, Grammatico A, Padeletti L; MINERVA Investigators. Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial. Eur Heart J. 2014 Sep 14;35(35):2352-62. doi: 10.1093/eurheartj/ehu165. Epub 2014 Apr 25.
Funck RC, Boriani G, Manolis AS, Puererfellner 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. doi: 10.1016/j.ahj.2008.05.004.
Other Identifiers
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MNV-20-171005
Identifier Type: -
Identifier Source: org_study_id
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