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RECRUITING
NCT05904548
NA

Atrial Flutter Ablation in the iCMR

Sponsor: Imricor Medical Systems

View on ClinicalTrials.gov

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.

Official title: Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2024-06-20

Completion Date

2026-12-31

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DEVICE

RF Ablation

RF ablation for type I atrial flutter under iCMR guidance

Locations (6)

Johns Hopkins University (JHU)

Baltimore, Maryland, United States

University of Virginia (UVA)

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

l'institut Cardiologique Paris Sud (ICPS)

Massy, France

Amsterdam University Medical Center (AUMC)

Amsterdam, Netherlands

University Hospital of Vaud (CHUV)

Lausanne, Switzerland