Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC
About this trial
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
Qualifiers
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.
Disqualifiers
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
Documented ventricular arrhythmia appropriate for catheter ablation.
Trial design
Treatments tested in this trial
- Catheter ablation
Treatment groups
20,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Biosense Webster, Inc.
Collaborator
Source ClinicalTrials.gov