Actively Recruiting
VT Ablation in the iCMR
Led by Imricor Medical Systems · Updated on 2026-01-08
64
Participants Needed
3
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VT Ablation in the iCMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 or uncontrolled stroke risks
- Class IV Heart Failure
- Ejection Fraction (EF) less than 25%
- Patients with a glomerular filtration rate (GFR) less than 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 less than 12 months
- Enrollment in another study without sponsor approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Herzzentrum Leipzig
Leipzig, Saxony, Germany, 04289
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
3
HagaZiekenhuis
The Hague, Netherlands, 2545 AA
Not Yet Recruiting
Research Team
K
Kate Lindborg, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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