VT Ablation in the iCMR (VISABL-VT)

Imricor Medical Systems

Status: Enrolling

Conditions: Ventricular Tachycardia

Treatments: Device: Vision-MR Ablation Catheter 2.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT05543798

VISABL-VT

Details and patient eligibility

About

The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)
• Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure
• Diagnosis of Ischemic Cardiomyopathy
• AAD therapy refractory, contraindicated, not tolerated, or not desired
• 18 years or older

Exclusion criteria

• Implanted with non-MR compatible medical devices or contraindicated for an MRI
• Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure)
• Thrombocytopenia or coagulopathy
• Mechanical mitral and/or aortic valve precluding access to the left ventricle
• Severe aortic stenosis
• Myocardial infarction requiring stent implantation within 90 days of procedure
• Previous cardiac surgery within 60 days of procedures
• Known/uncontrolled stroke risks
• Class IV Heart Failure
• Ejection Fraction (EF) < 25%
• Patients with a glomerular filtration rate (GFR) < 30
• Women who are pregnant
• Allergy to contrast agents (e.g., Gadolinium)
• Active infection
• Known or suspected myxoma
• Unstable angina
• Patients who do not tolerate anticoagulation therapy
• Previous intertribal septal patch or prosthetic atrial septal defect closure device
• Life expectancy < 12 months
• Enrollment in another study without sponsor approval

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

64 participants in 1 patient group

Non-Randomized

Experimental group

Description:

All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0

Treatment:

Device: Vision-MR Ablation Catheter 2.0