Clinical trial NCT00293241: PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
Official title: PreFER MVP for Elective Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Keywords: Pacemaker or ICD replacement
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant
timeFrame: Implant to 2 years post-implant
Secondary outcomes:
measure: Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.
timeFrame: Implant to 2 years post-implant
measure: Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant
timeFrame: Implant to 2 years post-implant
measure: Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant
timeFrame: Implant to 2 years post-implant
measure: Ventricular Pacing Percentage
timeFrame: Implant to 2 years post-implant
measure: Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time
timeFrame: Implant to 2 years post-implant
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: Baseline, one year and 2 year post-implant
measure: Change in Use of Anticoagulation
timeFrame: Implant to 2 years post-implant
measure: Change in the Use of Cardiovascular Medication Over Time
timeFrame: Implant to 2 years post-implant
measure: Incidence of High Voltage Therapies
timeFrame: Implant to 2 years post-implant
measure: Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant
timeFrame: Implant to 2 years post-implant
measure: Stroke
timeFrame: Implant to 2 years post-implant
measure: Number of Cardiovascular Related Hospitalizations
timeFrame: Implant to 4 years post-implant
measure: Duration of Cardiovascular Related Hospitalizations
timeFrame: Implant to 4 years post-implant
measure: Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients
timeFrame: Implant to 2 years post-implant
measure: Change in PR Interval, Change in QRS Duration and Change in P-wave Duration
timeFrame: Implant to 2 years post-implant
measure: Patient Symptoms
timeFrame: Implant to 2 years post-implant
measure: Atrial Pacing Percentage
timeFrame: 2 years post-implant
measure: Health State
timeFrame: 2 years post-implant
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Medtronic Bakken Research Center
Study officials:
affiliation: Centre Cardiologique du Nord, Saint-Denis, France
name: Oliver Piot, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Valencia, Spain
name: Aurelio Quesada, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium
name: De Roy, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: San Filippo Neri Hospital, Rome, Italy
name: Renato Ricci, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Como S. Anna Hospital, Como, Italy
name: Gianluca Botto, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultní nemocnice Brno Bohunice, Brno, Czech Republic
name: Milan Kozak, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.