Atrial Flutter Ablation in the iCMR

Atrial Flutter Typical Clinical Trial

— VISABL-AFL  

Official title:

Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904548
• Other study ID #: VISABL-AFL
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Imricor Medical Systems
• Contact: Kate Lindborg, PhD
• Phone: 9528188400
• Email: kate.lindborg[@]imricor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Atrial Flutter Typical

Intervention

Device:
• RF Ablation
RF ablation for type I atrial flutter under iCMR guidance

Locations

Country	Name	City	State
France	l'institut Cardiologique Paris Sud (ICPS)	Massy
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Imricor Medical Systems

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: Bi-directional block confirmation	Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator & irrigation pump.	Time of procedure, following delivery of last ablation energy delivery point
Primary	Primary Safety Endpoint: Composite of serious cardiovascular adverse events	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	7-days post procedure
Secondary	Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days	The percent of subjects free of documented type I atrial flutter recurrence	3 months (90 days)
Secondary	Chronic Safety Endpoint: all serious adverse event rate for duration of study	Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee	3 months (90 days)