Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Recruiting now
Conditions studied: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular Arrhythmia
In brief
The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.
Key facts
- Study ID
- NCT04088071
- Run by
- Heart Rhythm Clinical and Research Solutions, LLC
- People needed
- 20000
- Starts
- 2018-01-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
- >18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
You may not qualify if…
- 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)
- In the opinion of the investigator, any known contraindication to an ablation procedure
- CORE VA Cohort
- Inclusion Criteria:
- Documented ventricular arrhythmia appropriate for catheter ablation.
- >18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
- Exclusion Criteria:
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
- In the opinion of the investigator, any known contraindication to an ablation procedure.
Where it is running
- Prairie Education and Research — Springfield, Illinois, United States (enrolling)
- Cardiology Associates of Mobile — Mobile, Alabama, United States (enrolling)
- Grandview Medical Center — Birmingham, Alabama, United States (enrolling)
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
- Keck School of Medicine — Los Angeles, California, United States (enrolling)
- Valley Heart Rhythm Specialists — Chandler, Arizona, United States (enrolling)
- Community Memorial Hospital — Ventura, California, United States (enrolling)
- Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
- The Medical Center of Aurora — Aurora, Colorado, United States (enrolling)
- Colorado Heart and Vascular — Golden, Colorado, United States (enrolling)
- South Denver Cardiology — Littleton, Colorado, United States (enrolling)
- Ascension St. Vincent's — Jacksonville, Florida, United States (enrolling)
- HCA Florida Mercy Hospital — Miami, Florida, United States (enrolling)
- Naples Community Hospital — Naples, Florida, United States (enrolling)
- Ascension Sacred Heart — Pensacola, Florida, United States (enrolling)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
- Baycare Health Tampa — Tampa, Florida, United States (enrolling)
- Baycare Health System — Winterhaven, Florida, United States (enrolling)
- Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
- Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
- The Queen's Medical Center — Honolulu, Hawaii, United States (enrolling)
- Northshore University Health System — Evanston, Illinois, United States (enrolling)
- Midwest Cardiovascular Institute — Naperville, Illinois, United States (enrolling)
- Ascension St. Vincent's Hospital — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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