PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MVP ON

Managed Ventricular Pacing programmed on

Group Type OTHER

Managed Ventricular Pacing programmed ON/OFF

Intervention Type DEVICE

Device programming

MVP OFF

Managed Ventricular Pacing programmed off: conventional pacing

Group Type OTHER

Managed Ventricular Pacing programmed ON/OFF

Intervention Type DEVICE

Device programming

Interventions

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Managed Ventricular Pacing programmed ON/OFF

Device programming

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No