Ventricular Tachycardia
Conditions
Brief 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.
Interventions
DEVICEVision-MR Ablation Catheter 2.0
Catheter ablation of ventricular tachycardia
Sponsors
Imricor Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | Perioperative/Periprocedural | Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0 |
| Primary Safety Endpoint | 7 days | Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint | 6 months | 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. |
Countries
Germany, Netherlands
Contacts
Primary ContactKate Lindborg, Phd
Outcome results
None listed