Ablation treatment for atrial flutter using advanced imaging techniques
Official title: Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Run by Imricor Medical Systems · NCT05904548 · Data updated 2026-11-12
This study is testing a new way to treat atrial flutter using advanced imaging techniques to see if a special catheter can safely help patients feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 91 (estimated) |
| Sponsor | Imricor Medical Systems Industry-sponsored |
| Locations | 6 sites (Baltimore, Maryland and 5 other locations) |
| Status | Recruiting |
| Started | June 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT05904548 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a documented history of type I atrial flutter.
✕Probably not a fit
Patients with contraindications for MRI procedures or those who have had recent cardiac events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center trial aimed at evaluating the safety and efficacy of radiofrequency (RF) ablation for type-I atrial flutter. This procedure utilizes the Vision-MR Ablation Catheter 2.0 within an interventional Cardiac Magnetic Resonance (iCMR) environment. Patients eligible for this trial must have experienced at least one documented episode of atrial flutter in the past six months and be 18 years or older. The study will assess outcomes related to the effectiveness of the ablation technique in a controlled setting.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients suffering from atrial flutter.
How similar studies have gone: Other studies have shown promising results with RF ablation techniques, suggesting potential success for this novel application in the iCMR environment.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Johns Hopkins University (JHU)
Baltimore, Maryland, United States Recruiting -
University of Virginia (UVA)
Charlottesville, Virginia, United States Recruiting -
Virginia Commonwealth University
Richmond, Virginia, United States Recruiting -
l'institut Cardiologique Paris Sud (ICPS)
Massy, France Recruiting -
Amsterdam University Medical Center (AUMC)
Amsterdam, Netherlands Recruiting -
University Hospital of Vaud (CHUV)
Lausanne, Switzerland Recruiting
Study contacts
- Study coordinator: Kate Lindborg
- Email: kate.lindborg@imricor.com
- Phone: 952-818-8400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing two methods for catheter ablation of atrial flutter
This study is testing whether a new way of doing catheter ablation for atrial flutter can be safer and more effective than the standard method.
-
Radiofrequency ablation for ventricular tachycardia in patients with ischemic cardiomyopathy
This study is testing a new procedure using radiofrequency ablation to see if it can safely help people with ischemic cardiomyopathy who have frequent episodes of fast heartbeats that don't respond to medication.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.