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NCT04088071
Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular Arrhythmia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 20000
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
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.
Eligibility Criteria
REAL AF Cohort
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.
Source: ClinicalTrials.gov (NCT04088071). StuddyBuddy aggregates publicly available trial information.