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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imricor Medical Systems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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