Status:
COMPLETED
LEAF - Low Energy In Atrial Fibrillation
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Atrial Tachyarrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional...
Detailed Description
Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtro...
Eligibility Criteria
Inclusion
- ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.
Exclusion
- Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00157781
Start Date
August 1 2000
End Date
November 1 2003
Last Update
July 3 2025
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