Atrial Flutter Ablation in the iCMR (VISABL-AFL)

April 8, 2026 updated by: Imricor Medical Systems

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Massy, France, 91300
        • Recruiting
        • l'institut Cardiologique Paris Sud (ICPS)
        • Principal Investigator:
          • Laurent Fiorina, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam University Medical Center (AUMC)
        • Principal Investigator:
          • Michiel J.B. Kemme, MD
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Recruiting
        • University Hospital of Vaud (CHUV)
        • Principal Investigator:
          • Juerg Schwitter, MD
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University (JHU)
        • Principal Investigator:
          • Aravindan Kolandaivelu, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • University of Virginia (UVA)
        • Principal Investigator:
          • Kenneth Bilchick, MD
      • Richmond, Virginia, United States, 23284
        • Not yet recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Ajay Pillai, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
  • Patient 18 years and older

Exclusion Criteria:

  • Contraindications for MRI procedures
  • Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the 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 right atrium 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vision-MR Atrial Flutter Ablation
Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.
Device: RF Ablation
RF ablation for type I atrial flutter under iCMR guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint: Bi-directional block confirmation
Time Frame: Time of procedure, following delivery of last ablation energy delivery point
Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator & irrigation pump.
Time of procedure, following delivery of last ablation energy delivery point
Primary Safety Endpoint: Composite of serious cardiovascular adverse events
Time Frame: 7-days post procedure

A composite of the following serious adverse events as adjudicated by an independent clinical events committee:

  • Cardiac perforation/tamponade
  • Cerebrovascular accident (CVA)
  • Transient ischemic attack (TIA)
  • Complete heart block
  • Myocardial infarction
  • Pulmonary embolism
  • MR-related serious adverse events
  • Unanticipated device related serious adverse events
  • Death
7-days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
Time Frame: 3 months (90 days)
The percent of subjects free of documented type I atrial flutter recurrence
3 months (90 days)
Chronic Safety Endpoint: all serious adverse event rate for duration of study
Time Frame: 3 months (90 days)
Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
3 months (90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imricor Medical Systems

Investigators

  • Study Director: Kate Lindborg, Imricor Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISABL-AFL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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