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New treatment option for Ventricular Tachycardia
Official title VT Ablation in the iCMR
ClinicalTrials.gov ID: NCT05543798
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Roll-in people only: Documentation of premature ventricular contractions indicated for ablation therapy (people may or may not be diagnosed with...
- 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 likely can't join if
- 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
See the full eligibility criteria
- Roll-in people only: Documentation of premature ventricular contractions indicated for ablation therapy (people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Leipzig, Saxony, Germany
- Amsterdam, Netherlands
- The Hague, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leipzig, Saxony, Germany; Amsterdam, Netherlands; The Hague, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.