PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

This study has been completed.

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00294645

Purpose

The purpose of this study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink Network versus patients who are followed via routine office visits augmented by TTM.

Condition	Intervention
Bradycardia Arrhythmia	Device: Implantable Pulse Generator (IPG) Device: IPG diagnostics & remote data access

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pacemaker Remote Follow-up Evaluation and Review

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Rate of first diagnosis of clinically actionable events

Secondary Outcome Measures:

Frequency of actions taken in response to the diagnosis of clinically actionable events
Rate of first diagnosis for each type of clinically actionable event.

Estimated Enrollment:	900
Study Start Date:	April 2004
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has been previously implanted with a dual chamber or single chamber EnPulse, Kappa 900, or Adapta Device.
Patient agrees to complete all required follow-up transmissions and in-office visits.
Patient is capable of operating the TTM monitor and Medtronic CareLink monitor.

Exclusion Criteria:

Patient is an immediate candidate for an ICD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294645

Show 45 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Study Chair:

PREFER Study Team

Medtronic

More Information

Study ID Numbers:	701
Study First Received:	February 20, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00294645
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Remote Follow-up
Diagnostic
Bradycardia

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009