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: Not yet recruiting

Administrative data

• NCT number: NCT05904548
• Other study ID #: VISABL-AFL
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: June 2023
• 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: Not yet recruiting
• Enrollment: 91
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• 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
• 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imricor Medical Systems

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)