VT Ablation in the iCMR
ConditionVentricular Tachycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImricor Medical Systems
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vision-MR Ablation Catheter 2.0
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov