Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry
Heart Rhythm Clinical and Research Solutions, LLC
15,000 participants
Jan 1, 2018
OBSERVATIONAL
Conditions
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 registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Eligibility
Inclusion Criteria5
- 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
- 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 Criteria4
- 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
Interventions
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
Locations(66)
View Full Details on ClinicalTrials.gov
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NCT04088071