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

February 16, 2006
June 26, 2015
February 2006
August 2011   (final data collection date for primary outcome measure)
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.
Time to first event of death or cardiovascular (CV) hospitalization
Complete list of historical versions of study NCT00293241 on ClinicalTrials.gov Archive Site
  • 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.
  •  Demonstrate that fewer patients experience AT/AF with MVP programmed ON compared to patients with MVP OFF and common device programming.
  •  Compare the percentage ventricular pacing in both arms.
  •  Compare the change in, Left Ventricular Ejection Fraction (LVEF) over time in both arms.
  •  Compare the change in NYHA Functional Class over time.
  •  Compare the change in use of Anticoagulation in both arms.
  •  Compare the change in the use of cardiovascular medication over time in both arms.
  •  Compare the incidence of high voltage therapies in both groups.
  •  Compare the hazard rate for all cause mortality in both arms.
  •  Compare the hazard rate for stroke in both arms.
  •  Compare the hazard rate for amount and duration of cardiovascular related hospitalization in both arms.
  •  Evaluate incidence of Class I Pacemaker Indication in ICD patients in both arms.
  •  Compare patient symptoms in both arms.
  •  Compare brain natriuretic peptide (BNP) levels in both arms.
  •  Compare the percentage atrial pacing in both arms.
  •  Evaluate health economics in both arms
Not Provided
Not Provided
 
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
PreFER MVP for Elective Replacement

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cardiovascular Diseases
Device: Managed Ventricular Pacing programmed ON/OFF
Device programming
  • MVP ON
    Managed Ventricular Pacing programmed on
    Intervention: Device: Managed Ventricular Pacing programmed ON/OFF
  • MVP OFF
    Managed Ventricular Pacing programmed off: conventional pacing
    Intervention: Device: Managed Ventricular Pacing programmed ON/OFF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00293241
Version 2-Aug 21, 2007
Yes
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
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
Medtronic Bakken Research Center
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP