Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2025-04-10
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-Randomized
All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0
Vision-MR Ablation Catheter 2.0
Catheter ablation of ventricular tachycardia
Interventions
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Vision-MR Ablation Catheter 2.0
Catheter ablation of ventricular tachycardia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Imricor Medical Systems
INDUSTRY
Responsible Party
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Locations
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Herzzentrum Leipzig
Leipzig, Saxony, Germany
Amsterdam UMC
Amsterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Sebastian Hilbert
Role: primary
Ivo Van Der Bilt, MD, PhD
Role: primary
Hemanth Ramanna, MD, PhD
Role: backup
Other Identifiers
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VISABL-VT
Identifier Type: -
Identifier Source: org_study_id
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