Real-world Experience of Catheter Ablation Using CARTO Technologies
for Treating Paroxysmal and Persistent Atrial Fibrillation and Ventricular Arrhythmias
Led by Heart Rhythm Clinical and Research Solutions, LLC · Updated on 2026-07-09
20000
Participants Needed
70
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research evaluates the real-world safety and long-term effectiveness of catheter ablation procedures in treating patients with paroxysmal atrial fibrillation PAF, persistent atrial fibrillation PsAF, and ventricular arrhythmias VA. The study is an observational, prospective, multi-center registry collecting clinical data from the use of commercially available CARTO technologies by Biosense Webster, Inc. These procedures are performed under usual care by healthcare practitioners.
Participants receive catheter ablation using Biosense Websters CARTO devices such as THERMOCOOL SMARTTOUCH, QDOT MICRO, and VARIPULSE catheters. The registry includes patients with symptomatic PAF or PsAF who are candidates for ablation, as well as patients with documented ventricular arrhythmias suitable for catheter ablation. The ablations follow standard care practices at participating sites, and future new ablation technologies may also be included as they become available.
Throughout the study, participants undergo routine baseline and follow-up evaluations aligned with standard care without extra visits required by the registry. Researchers monitor outcomes including procedural efficiency, acute safety within 30 days post-ablation, arrhythmia recurrence after a 90-day blanking period, and long-term effectiveness up to 12 months. Patient-reported symptoms, medication usage, and clinical scores such as CHA2DS2VASC are also collected to assess the overall impact of the ablation procedures.
CONDITIONS
Brief Title
Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Research Team
J
Jennifer White, MS
J
Jose Osorio, MD
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Symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PsAF) subjects who are candidates for catheter ablation
Adults aged over 18 years
Treated with Biosense Webster Inc. ablation technologies
Includes repeat ablations even if prior procedure used non-BWI catheter
Able and willing to participate in baseline and follow-up evaluations
Willing and able to provide informed consent
Documented ventricular arrhythmia appropriate for catheter ablation (CORE VA cohort)
Age over 18 years (CORE VA cohort)
Willing and able to participate in baseline and follow-up evaluations (CORE VA cohort)
Willing and able to provide informed consent (CORE VA cohort)
You will not qualify if you...
Participation in an investigational drug or device clinical trial or any trial that dictates treatment plan
Long-standing persistent atrial fibrillation (lasting more than one year)
Known contraindication to catheter ablation as judged by the investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Catheter Ablation Treatment
Duration - One day (procedure day)
Participants undergo catheter ablation using Biosense Webster CARTO technologies according to their site's standard care.
1 procedure visit
Follow-up and Monitoring
Duration - Up to 12 months
Participants receive routine follow-up evaluations to monitor arrhythmia recurrence, safety, and other clinical outcomes up to 12 months after the ablation.
Scheduled follow-up visits as per standard care
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Heart Failure With Reduced Ejection Fraction (HFrEF)
Actively Recruiting
13 locations
Frequently Asked Questions
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Published Research Related To This Trial
Practice Patterns of Operators Participating in the Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) Registry.
Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry.
Jose Osorio, Andres F Miranda-Arboleda, Alejandro Velasco...
A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.
Allyson L Varley, Omar Kreidieh, Brigham E Godfrey...