Status:
WITHDRAWN
PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Medtronic
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Brief Summary
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation.
Detailed Description
Pulmonary vein isolation is now considered a cornerstone of all atrial fibrillation (AF) ablation procedures. In patients with paroxysmal AF, pulmonary vein isolation alone is usually sufficient. The ...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years
- Able and willing to give written informed consent
- Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
- Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide
Exclusion
- Previous ablation for AF
- Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
- Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
- Presence of severe valvular disease with the need for surgical correction
- AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
- Pregnant women or women of child bearing potential and not on reliable methods of birth control
- Second or third degree AV block, sinus pause \> 3 seconds, resting heart rate\< 30 bpm without permanent pacemaker
- History of drug-induced Torsades de Pointes or congenital long QT syndrome
- Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01877486
Start Date
January 1 2016
End Date
December 1 2016
Last Update
October 4 2016
Active Locations (1)
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1
Valley Hospital
Ridgewood, New Jersey, United States, 07450