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

NCT04088071 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Ventricular Arrhythmia

Interventions

DEVICE

Catheter ablation

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Heart Rhythm Clinical and Research Solutions, LLC

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088071 on ClinicalTrials.gov