VT Ablation in the iCMR

NCT ID: NCT05543798

Last Updated: 2026-01-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Vision-MR Ablation Catheter 2.0

Intervention Type DEVICE

Catheter ablation of ventricular tachycardia

Interventions

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Vision-MR Ablation Catheter 2.0

Catheter ablation of ventricular tachycardia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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/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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imricor Medical Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herzzentrum Leipzig

Leipzig, Saxony, Germany

Site Status NOT_YET_RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

HagaZiekenhuis

The Hague, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Germany Netherlands

Central Contacts

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Kate Lindborg, Phd

Role: CONTACT

9528188400

Facility Contacts

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Sebastian Hilbert

Role: primary

Michiel Kemme

Role: primary

+31 020-4442244

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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