Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Herzzentrum Leipzig
NOT_YET_RECRUITING
Leipzig
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
HagaZiekenhuis
NOT_YET_RECRUITING
The Hague
Contact Information
Primary
Kate Lindborg, Phd
kate.lindborg@imricor.com
9528188400
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2026-06
Participants
Target number of participants: 64
Treatments
Experimental: Non-Randomized
All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0
Related Therapeutic Areas
Sponsors
Leads: Imricor Medical Systems