Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Vision-MR Ablation Catheter 2.0

    Device

    Catheter ablation of ventricular tachycardia

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Non-RandomizedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Efficacy Endpoint

Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0

Time frame
Perioperative/Periprocedural
2

Primary Safety Endpoint

Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure

Time frame
7 days

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imricor Medical Systems

Lead sponsor

Source ClinicalTrials.gov
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