PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

NCT00293241 | Completed Phase 4 Results DMC

• 1 other identifier: Version 2-Aug 21, 2007
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

Pacemaker or ICD replacement

Outcome Measures

Primary Outcomes (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.

  Implant to 2 years post-implant

Secondary Outcomes (18)

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

  Implant to 2 years post-implant

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

  Implant to 2 years post-implant

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

  Implant to 2 years post-implant

• Ventricular Pacing Percentage

  Implant to 2 years post-implant

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

  Implant to 2 years post-implant

Study Arms (2)

MVP ON

OTHER

Managed Ventricular Pacing programmed on

Device: Managed Ventricular Pacing programmed ON/OFF

MVP OFF

OTHER

Managed Ventricular Pacing programmed off: conventional pacing

Device: Managed Ventricular Pacing programmed ON/OFF

Interventions

Managed Ventricular Pacing programmed ON/OFF DEVICE

Device programming

MVP OFF; MVP ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Bakken Research Center

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26142300 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Atrial pacing % was not collected at implant, device programming in the MVP off arm was more often non-compliant than in MVP on arm, and 25% of the case report forms were sent without device data, possibly influencing device data related objectives

Results Point of Contact

• Title: Lidwien Vainer
• Organization: Medtronic Bakken

lidwien.vainer@medtronic.com

+31 433566752

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 24, 2016
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

NL (1)