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Atrial Flutter Ablation in the iCMR

This study is testing a new way to treat typical atrial flutter, a type of irregular heartbeat. It uses a procedure called radiofrequency (RF) ablation with a special device called the Vision-MR Ablation Catheter 2.0, performed inside an iCMR (interventional cardiac magnetic resonance) environment. Researchers want to see how safe and effective this procedure is. You might be able to join if you are 18 or older and have had at least one episode of type I atrial flutter within the last six months. However, you cannot join if you have reasons not to have an MRI or cannot take certain anti-arrhythmic drugs. The study will look at how well the ablation blocks the irregular heart signals and any serious side effects within 7 days after the procedure. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 91 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured up to 7 days after the procedure.

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NCT05904548

Atrial Flutter Ablation in the iCMR

Recruiting
NAAges 18+InterventionalTreatment
Imricor Medical Systems
~91 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:RF Ablation

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint: Bi-directional block confirmation
Measured over Time of procedure, following delivery of last ablation energy delivery point
+1 more outcome measured

Conditions

Atrial Flutter Typical

Explore related trials

Atrial Flutter

Where it's being run

6 sites across 5 states
Virginia2
Maryland1
France1
Netherlands1
Switzerland1

Study leadership

  • Kate Lindborg · STUDY_DIRECTOR · Imricor Medical Systems, Inc.

Who to contact

Kate Lindborg
[email protected]
952-818-8400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Primary Efficacy Endpoint: Bi-directional block confirmationTime 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.

  • Primary Safety Endpoint: Composite of serious cardiovascular adverse events7-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