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NCT Number: NCT05904548

Atrial Flutter Ablation in the iCMR

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.

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Key information

Conditions

Atrial Flutter Typical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

l'institut Cardiologique Paris Sud (ICPS), Massy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF ablation

Device

RF ablation for type I atrial flutter under iCMR guidance

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Somerville

CONTACT

[email protected]

952-594-4138

Kate Lindborg

CONTACT

[email protected]

952-818-8400

Sponsors and collaborators

Lead sponsor

Imricor Medical Systems

Industry

Registry information

Official study title

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

Acronym: VISABL-AFL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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