VT Ablation in the iCMR

Ventricular Tachycardia Clinical Trial

— VISABL-VT  

Official title:

Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05543798
• Other study ID #: VISABL-VT
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• 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-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months

• 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/echocardiogram 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

• Class IV Heart Failure

• Ejection Fraction (EF) < 25%

• Patients with a glomerular filtration rate (GFR) < 30

• Women who are pregnant

• Life expectancy < 12 months

• Enrollment in another study without sponsor approval

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Vision-MR Ablation Catheter 2.0
Catheter ablation of ventricular tachycardia

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	Acute success defined as absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the investigational device.	30 minutes post procedure
Primary	Primary Safety Endpoint	Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure	7 days
Secondary	Secondary Efficacy Endpoint	Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.	6 months