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Atrial Flutter Ablation in the iCMR

Imricor Medical Systems · NCT05904548

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
91
US sites recruiting
3
Study start
June 20, 2024
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: RF Ablation

Conditions: Atrial Flutter Typical

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Johns Hopkins University (JHU)

    Baltimore, MD 21218

    Site contact: Aravindan Kolandaivelu, MD

  • University of Virginia (UVA)

    Charlottesville, VA 22903

    Site contact: Kenneth Bilchick, MD

  • Virginia Commonwealth University

    Richmond, VA 23284

    Site contact: Ajay Pillai, M.D. · 478-957-2109 · ajay.pillai@vcuhealth.org

Study contacts (from the official record)

  • Kate Lindborg · 952-818-8400 · kate.lindborg@imricor.com
  • Jennifer Somerville · 952-594-4138 · jennifer.somerville@imricor.com
Atrial Flutter Ablation in the iCMR (NCT05904548) | Bored Studies