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Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias

Sponsored by Heart Rhythm Clinical and Research Solutions, LLC

About this study

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.

The REAL Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of ablation using Biosense Webster, Inc. (BWI) CARTO technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available. Current clinical practice guidelines recommend ablation for ventricular arrhythmias (VA) and atrial fibrillation (AF)1,2. Therefore, REAL AF will include subjects with symptomatic paroxysmal AF (PAF), persistent AF (PsAF) who meet all eligibility criteria and in the opinion of the investigator, are candidates for AF catheter ablation. CORE-VA wil…

Where this study is enrolling (12)

Show all 12 locations

  • Brigham and Women's Hospital

    Boston, Massachusetts

    Call 617-732-5087

    This research site can be reached directly by phone. Call to ask about this study.

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  • Crouse Health System and Crouse Medical Practice

    Syracuse, New York

    I'm interested

  • Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)

    New York, New York

    I'm interested

  • Mount Carmel Columbus Cardiology Consultants

    Columbus, Ohio

    Call 614-546-4327

    This research site can be reached directly by phone. Call to ask about this study.

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  • Jackson-Madison County General Hospital

    Jackson, Tennessee

    I'm interested

  • Texas Cardiac Arrhythmia Foundation

    Austin, Texas

    I'm interested

  • University of Washington-Seattle

    Seattle, Washington

    I'm interested
Who can participate

Inclusion criteria

  • ✓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.

Exclusion criteria

  • ✕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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.