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Cardiovascular DiseasesPhase 4NCT00293241

PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

A Phase 4 study testing Managed Ventricular Pacing programmed ON/OFF in people with Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Managed Ventricular Pacing programmed ON/OFF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
1 siteNetherlands
Study dates
Feb 2006to Aug 2011
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Medtronic Bakken Research Center

    Maastricht

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Managed Ventricular Pacing programmed ON/OFF
Keywords
Pacemaker or ICD replacement
Medical subject headings
Cardiovascular Diseases

What participants receive

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

  • Managed Ventricular Pacing programmed ON/OFFDevice

    Device programming

Study groups in NCT00293241
Study groupRoleWhat they receive
MVP ONOtherManaged Ventricular Pacing programmed on
Receives: Device: Managed Ventricular Pacing programmed ON/OFF
MVP OFFOtherManaged Ventricular Pacing programmed off: conventional pacing
Receives: Device: Managed Ventricular Pacing programmed ON/OFF

What is being measured

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

  1. Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant

    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.

    Measured: Implant to 2 years post-implant

Secondary outcomes (18)

  1. Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.

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

    Measured: Implant to 2 years post-implant

  2. Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant

    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

    Measured: Implant to 2 years post-implant

  3. Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant

    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

    Measured: Implant to 2 years post-implant

  4. Ventricular Pacing Percentage

    Endpoint: Cumulative percentage ventricular pacing documented in the device memory

    Measured: Implant to 2 years post-implant

  5. Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time

    Endpoint: LVEF (%) difference between 2 year post implant and baseline

    Measured: Implant to 2 years post-implant

  6. Change in New York Heart Association (NYHA) Functional Class

    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.

    Measured: Baseline, one year and 2 year post-implant

  7. Change in Use of Anticoagulation

    Endpoint: Use of Anticoagulation at enrollment and every follow-up visit

    Measured: Implant to 2 years post-implant

  8. Change in the Use of Cardiovascular Medication Over Time

    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

    Measured: Implant to 2 years post-implant

  9. Incidence of High Voltage Therapies

    Endpoint: A high voltage therapy delivered

    Measured: Implant to 2 years post-implant

  10. Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant

    Time to patient death from any cause

    Measured: Implant to 2 years post-implant

  11. Stroke

    Endpoint: Stroke

    Measured: Implant to 2 years post-implant

  12. Number of Cardiovascular Related Hospitalizations

    Endpoint: Number of Cardiovascular hospitalizations per subject

    Measured: Implant to 4 years post-implant

  13. Duration of Cardiovascular Related Hospitalizations

    Endpoint: Duration of Cardiovascular Hospitalizations per subject

    Measured: Implant to 4 years post-implant

  14. Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients

    Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication

    Measured: Implant to 2 years post-implant

  15. Change in PR Interval, Change in QRS Duration and Change in P-wave Duration

    Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU

    Measured: Implant to 2 years post-implant

  16. Patient Symptoms

    Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup

    Measured: Implant to 2 years post-implant

  17. Atrial Pacing Percentage

    Endpoint: Cumulative percentage atrial pacing documented in the device memory

    Measured: 2 years post-implant

  18. Health State

    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.

    Measured: 2 years post-implant

Timeline

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

  1. First posted17 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00293241
Sponsor's protocol ID
Version 2-Aug 21, 2007
Status last verified
Jun 2015
First submitted
16 Feb 2006
Last updated
24 Jun 2016
Data monitoring committee
Yes

Publications

  • Ricci RP, Botto GL, Benezet JM, Nielsen JC, De Roy L, Piot O, Quesada A, Quaglione R, Vaccari D, Mangoni L, Grammatico A, Kozak M; PreFER MVP Investigators. Association between ventricular pacing and persistent atrial fibrillation in patients indicated to elective pacemaker replacement: Results of the Prefer for Elective Replacement MVP (PreFER MVP) randomized study. Heart Rhythm. 2015 Nov;12(11):2239-46. doi: 10.1016/j.hrthm.2015.06.041. Epub 2015 Jun 30.

    PubMed 26142300

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Managed Ventricular Pacing programmed ON/OFF in people with Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

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 6 inclusion and 8 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 24 Jun 2016. 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 Netherlands. 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 30 Jun 2015). 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?

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). 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 NCT00293241, which also lists 1 linked publication.

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 24 Jun 2016.

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Clinical Trial NCT00293241 | AzTrials