Status:
COMPLETED
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Bradycardia
Arrhythmia
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of the 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 pati...
Detailed Description
The Clinically Actionable Events (CAE) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The defined events are: 1. Atrial Tachycar...
Eligibility Criteria
Inclusion
- 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
- Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT00294645
Start Date
April 1 2004
End Date
April 1 2008
Last Update
October 19 2010
Active Locations (45)
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1
Scottsdale, Arizona, United States
2
Little Rock, Arkansas, United States
3
Washington D.C., District of Columbia, United States
4
Ormond Beach, Florida, United States