NCT00262119

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed
Last Updated

July 2, 2025

Status Verified

March 1, 2016

Enrollment Period

6.2 years

First QC Date

December 4, 2005

Results QC Date

May 9, 2014

Last Update Submit

June 30, 2025

Conditions

Atrial FibrillationHeart Failure, Congestive

Keywords

Physiological pacingAntitachycardia pacing therapies

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (18)

  • Death for All Causes at 2 Years

    2 years

  • Incidence of Permanent Atrial Fibrillation at 2 Years

    2 years

  • Incidence of Cardiovascular Hospitalizations at 2 Years

    2 years

  • Burden of Composite Clinical Endpoint

    2 years

  • Subjects' Symptoms

    2 years

  • +13 more secondary outcomes

Study Arms (3)

Control Group

ACTIVE COMPARATOR

PM programming according to actual clinical practice

Device: Pacemaker Medtronic EnRhythm

MVP Only

ACTIVE COMPARATOR

PM programming according to actual clinical practice + MVP algorithm ON

Device: Pacemaker Medtronic EnRhythm

DDDRP

ACTIVE COMPARATOR

PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON

Device: Pacemaker Medtronic EnRhythm

Interventions

Pacemaker Medtronic EnRhythmDEVICE

Pacemaker specific programming

Control GroupDDDRPMVP Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medtronic Italia S.p.A.

Rome, 00193, Italy

Location

Related Publications (9)

  • 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.

    PMID: 10805823BACKGROUND

  • 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.

    PMID: 12063369BACKGROUND

  • 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.

    PMID: 9519322BACKGROUND

  • 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.

    PMID: 9652562BACKGROUND

  • 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.

    PMID: 15145874BACKGROUND

  • 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.

    PMID: 9529267BACKGROUND

  • 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.

    PMID: 12932590BACKGROUND

  • 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.

    PMID: 24771721DERIVED

  • 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.

    PMID: 18760124DERIVED

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Senior Clinical Research Manager
Organization
Medtronic
andrea.grammatico@medtronic.com
0039-0632814225

Study Officials

  • 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

    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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2005

First Posted

December 6, 2005

Study Start

February 1, 2006

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

July 2, 2025

Results First Posted

June 11, 2014

Record last verified: 2016-03

Locations

IT(1)