Atrial Flutter Ablation in the iCMR

Launched by IMRICOR MEDICAL SYSTEMS · Jun 12, 2023

Keywords

ClinConnect Summary

The VISABL-AFL clinical trial is studying a treatment called radiofrequency ablation for patients with type-I atrial flutter, a heart condition where the heart beats irregularly. This trial aims to find out how safe and effective this treatment is when performed with a specific device called the Vision-MR Ablation Catheter 2.0 in a special environment designed for MRI scans. The trial is currently looking for participants aged 18 and older who have had at least one episode of this heart condition within the past six months.

To be eligible, patients should not have certain medical conditions that could complicate the procedure, such as recent heart attacks or surgeries, and they should be able to stop specific heart medications before the treatment. Participants in this trial can expect to undergo the ablation procedure, which aims to help restore a normal heart rhythm. It's important to note that this is a research study, so patients will be monitored closely throughout the process to ensure their safety and gather information on the treatment's effectiveness.

Gender

ALL

Eligibility 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