Status:
RECRUITING
Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Lead Sponsor:
Heart Rhythm Clinical and Research Solutions, LLC
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the ...
Detailed Description
The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e....
Eligibility Criteria
Inclusion
- Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- 18 years of age or older
- De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
- Willing and able to provide informed consent, if applicable
Exclusion
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- Long-standing persistent AF (AF greater than one year's duration)
- Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
- In the opinion of the investigator, any known contraindication to an ablation procedure
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT04088071
Start Date
January 1 2018
End Date
December 31 2027
Last Update
August 7 2025
Active Locations (66)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Grandview Medical Center
Birmingham, Alabama, United States, 35243
3
Cardiology Associates of Mobile
Mobile, Alabama, United States, 36695
4
Valley Heart Rhythm Specialists
Chandler, Arizona, United States, 85224