Atrial Flutter Ablation in the iCMR

Last updated: April 14, 2025
Sponsor: Imricor Medical Systems
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Atrial Fibrillation

Atrial Flutter

Treatment

RF Ablation

Clinical Study ID

NCT05904548
VISABL-AFL
  • Ages > 18
  • All Genders

Study Summary

The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient indicated for type I atrial flutter ablations with at least 1 documentedepisode of type I atrial flutter within 6 months (180 days) of enrollment

  • Patient 18 years and older

Exclusion

Exclusion Criteria:

  • Contraindications for MRI procedures

  • Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed forthe treatment of type I atrial flutter stopped on the day of the procedure

  • Previous CTI ablation procedures

  • Myocardial infarction within 60 days of enrollment

  • Current unstable angina

  • Cardiac surgery within 90 days of enrollment

  • Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment

  • Thrombocytosis or thrombocytopenia

  • Contraindication to anticoagulation therapy

  • Currently documented intracardiac thrombus or myxoma

  • Implantation of permanent leads of an implantable device in or through the rightatrium within 90 days of enrollment

  • Prosthetic valve through which the catheter must pass

  • Interatrial baffle or patch through which the catheter must pass

  • Moderate or severe tricuspid valve regurgitation or stenosis

  • Uncompensated congestive heart failure

  • Active systemic infection

  • Pregnancy or if subject plans to become pregnant during the trial

  • Uncontrolled hyperthyroidism

  • Any other significant uncontrolled or unstable medical condition

  • Enrollment in any concurrent study without Imricor written approval

  • Life expectancy of less than or equal to 2 years (730 days) per physician opinion

Study Design

Total Participants: 91
Treatment Group(s): 1
Primary Treatment: RF Ablation
Phase:
Study Start date:
June 20, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • l'institut Cardiologique Paris Sud (ICPS)

    Massy, 91300
    France

    Active - Recruiting

  • Amsterdam University Medical Center (UMC)

    Amsterdam,
    Netherlands

    Active - Recruiting

  • University Hospital of Vaud (CHUV)

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.