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
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.
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.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation. The objective of this registry is to assess clinical outcomes, including procedural e…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Enrolled in an investigational drug or device clinic…
Interventions
- DeviceCatheter ablation
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
Locations (66)
- University of Alabama at BirminghamBirmingham, Alabama
- Grandview Medical CenterBirmingham, Alabama
- Cardiology Associates of MobileMobile, Alabama
- Valley Heart Rhythm SpecialistsChandler, Arizona
- Arrhythmia Research GroupJonesboro, Arkansas
- Keck School of MedicineLos Angeles, California