PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00293241
First received: February 16, 2006
Last updated: June 26, 2015
Last verified: June 2015
  Purpose

The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.


Condition Intervention Phase
Cardiovascular Diseases
Device: Managed Ventricular Pacing programmed ON/OFF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: PreFER MVP for Elective Replacement

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]

    Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.

    Hospitalization is defined as:

    • admission to hospital involving one overnight stay or
    • emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition

    Cardiovascular is defined as new or worsening:

    • heart failure (HF),
    • angina,
    • myocardial infarction (MI),
    • any arrhythmia,
    • stroke,
    • transient ischemic attack (TIA),
    • acute peripheral vascular emergencies,
    • pulmonary embolism.


Secondary Outcome Measures:
  • Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant

  • Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]

    Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:

    • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF or
    • a cardioversion was done to terminate AT/AF or
    • the patient is during 2 consecutive follow-up (FU) visits in AT/AF

  • Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]

    Time to development of permanent AF fulfilling one of the following criteria:

    • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or
    • 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient

  • Ventricular Pacing Percentage [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Cumulative percentage ventricular pacing documented in the device memory

  • Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: LVEF (%) difference between 2 year post implant and baseline

  • Change in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline, one year and 2 year post-implant ] [ Designated as safety issue: No ]

    Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.

    II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

    III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.

    IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.


  • Change in Use of Anticoagulation [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Use of Anticoagulation at enrollment and every follow-up visit

  • Change in the Use of Cardiovascular Medication Over Time [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant

  • Incidence of High Voltage Therapies [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: A high voltage therapy delivered

  • Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Time to patient death from any cause

  • Stroke [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Stroke

  • Number of Cardiovascular Related Hospitalizations [ Time Frame: Implant to 4 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Number of Cardiovascular hospitalizations per subject

  • Duration of Cardiovascular Related Hospitalizations [ Time Frame: Implant to 4 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Duration of Cardiovascular Hospitalizations per subject

  • Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication

  • Change in PR Interval, Change in QRS Duration and Change in P-wave Duration [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU

  • Patient Symptoms [ Time Frame: Implant to 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup

  • Atrial Pacing Percentage [ Time Frame: 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Cumulative percentage atrial pacing documented in the device memory

  • Health State [ Time Frame: 2 years post-implant ] [ Designated as safety issue: No ]
    Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.


Enrollment: 630
Study Start Date: February 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MVP ON
Managed Ventricular Pacing programmed on
Device: Managed Ventricular Pacing programmed ON/OFF
Device programming
MVP OFF
Managed Ventricular Pacing programmed off: conventional pacing
Device: Managed Ventricular Pacing programmed ON/OFF
Device programming

Detailed Description:

A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.

Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.

MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.

The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [VDD]) for a minimum time duration of 2 years
  • Planned to be replaced or replaced with a device including the MVP feature
  • Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
  • Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion
  • Have signed the informed consent
  • Have no need to change the pacing mode or the atrioventricular (AV) intervals.

Exclusion Criteria:

  • Patients with a cardiac resynchronization therapy (CRT) indication
  • Permanent AF
  • Permanent AV block
  • Inability to complete follow-up visits at a study center.
  • Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
  • Planned cardiovascular intervention
  • Inclusion in another clinical trial that will affect the objectives of this study
  • Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.
  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: NCT00293241

Locations
Netherlands
Medtronic Bakken Research Center
Maastricht, Netherlands
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Oliver Piot, Dr. Centre Cardiologique du Nord, Saint-Denis, France
Principal Investigator: Aurelio Quesada, Dr. Hospital General Universitario de Valencia, Spain
Principal Investigator: De Roy, Prof. Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium
Principal Investigator: Renato Ricci, Dr. San Filippo Neri Hospital, Rome, Italy
Principal Investigator: Gianluca Botto, Dr. Como S. Anna Hospital, Como, Italy
Principal Investigator: Milan Kozak, Dr. Fakultní nemocnice Brno Bohunice, Brno, Czech Republic
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00293241     History of Changes
Other Study ID Numbers: Version 2-Aug 21, 2007
Study First Received: February 16, 2006
Results First Received: October 9, 2014
Last Updated: June 26, 2015
Health Authority: France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Pacemaker or ICD replacement

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015