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

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Ventricular Arrhythmia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Catheter ablation — DEVICE
  Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., 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.

Study Details

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 Dates

First listed

Sep 12, 2019

Start date

Jan 1, 2018

Status verified

Jul 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

20,000 participants (estimated)

Arms

• Arm: REAL AF
  Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.
• Arm: CORE VA
  Subjects with documented ventricular arrhythmia appropriate for catheter ablation, greater than 18 years of age, will be treated with Biosense Webster Inc. ablation technologies, and are willing and able to participate in baseline and follow up evaluations.

Primary Outcome Measure

Effectiveness at 90 days [ Time Frame: 90 days ]

Central Contacts

• Jennifer White, MS
  1-629-335-8261
  [email protected]
• Jose Osorio, MD
  [email protected]

Locations (68)

Find similar trials in Birmingham, AL

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