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Atrial FibrillationPhase 4NCT00262119

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

A Phase 4 study testing Pacemaker Medtronic EnRhythm in people with Atrial Fibrillation and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pacemaker Medtronic EnRhythm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
1 siteItaly
Study dates
Feb 2006to Apr 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Medtronic Italia S.p.A.

    Rome, 00193

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Pacemaker Medtronic EnRhythm
Keywords
Physiological pacing, Antitachycardia pacing therapies
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pacemaker Medtronic EnRhythmDevice

    Pacemaker specific programming

Study groups in NCT00262119
Study groupRoleWhat they receive
Control GroupActive comparatorPM programming according to actual clinical practice
Receives: Device: Pacemaker Medtronic EnRhythm
MVP OnlyActive comparatorPM programming according to actual clinical practice + MVP algorithm ON
Receives: Device: Pacemaker Medtronic EnRhythm
DDDRPActive comparatorPM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Receives: Device: Pacemaker Medtronic EnRhythm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years

    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.

    Measured: 2 years

Secondary outcomes (18)

  1. Death for All Causes at 2 Years

    Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years

    Measured: 2 years

  2. Incidence of Permanent Atrial Fibrillation at 2 Years

    Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years

    Measured: 2 years

  3. Incidence of Cardiovascular Hospitalizations at 2 Years

    Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years

    Measured: 2 years

  4. Burden of Composite Clinical Endpoint

    Measured: 2 years

  5. Subjects' Symptoms

    Measured: 2 years

  6. Heart Failure Medications

    Measured: 2 years

  7. Cumulative Percentage of Ventricular Pacing

    Measured: 2 years

  8. Cardiovascular Death

    Measured: 2 years

  9. Any Hospitalization

    Measured: 2 years

  10. Atrial Fibrillation Burden

    Measured: 2 years

  11. Persistent Atrial Fibrillation (AF)

    Measured: 2 years

  12. Adverse Events

    Measured: 2 years

  13. Development of Atrioventricular (AV) Block and Pacemaker Dependency

    Measured: 2 years

  14. Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism

    Measured: 2 years

  15. Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation

    Measured: 2 years

  16. Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay

    Measured: 2 years

  17. Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients

    Measured: 2 years

  18. Frequency, Type, and Associated Cost of Health Care Utilization and Utility

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startFeb 2006
  3. Primary completionApr 2012
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262119
Sponsor's protocol ID
MNV-20-171005
Status last verified
Mar 2016
First submitted
4 Dec 2005
Last updated
2 Jul 2025

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. doi: 10.1056/NEJM200005113421902.

    PubMed 10805823

  • 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.

    PubMed 12063369

  • 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.

    PubMed 9519322

  • 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.

    PubMed 9652562

  • 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.

    PubMed 15145874

  • 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.

    PubMed 9529267

  • 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.

    PubMed 12932590

  • 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.

    PubMed 24771721

  • 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.

    PubMed 18760124

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pacemaker Medtronic EnRhythm in people with Atrial Fibrillation and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262119, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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