Atrial Flutter Ablation in the iCMR (VISABL-AFL)

Imricor Medical Systems

Status: Enrolling

Conditions: Atrial Flutter Typical

Treatments: Device: RF Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05904548

VISABL-AFL

Details and patient eligibility

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.

Enrollment: 91 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Vision-MR Atrial Flutter Ablation

Experimental group

Description:

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.

Treatment:

Device: RF Ablation