Ventricular TachycardiaVISABL-VTNCT05543798
VT Ablation in the iCMR
A study testing Vision-MR Ablation Catheter 2.0 in people with Ventricular Tachycardia, run by Imricor Medical Systems at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Vision-MR Ablation Catheter 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Michiel Kemme, +31 020-4442244, m.kemme@amsterdamumc.nl
- Not yet recruiting
HagaZiekenhuis
The Hague, 2545 AA
Ivo Van Der Bilt, MD, PhD
Hemanth Ramanna, MD, PhD
Germany1 site, 1 recruiting
- Not yet recruiting
Herzzentrum Leipzig
Leipzig, Saxony, 04289
Sebastian Hilbert
About this study
Official title: Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
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
- Ventricular Tachycardia
- Being tested
- Vision-MR Ablation Catheter 2.0
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision-MR Ablation Catheter 2.0Device
Catheter ablation of ventricular tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Non-Randomized | Experimental | All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0 Receives: Device: Vision-MR Ablation Catheter 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0
Measured: Perioperative/Periprocedural
Primary Safety Endpoint
Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
Measured: 7 days
Secondary outcomes (1)
Secondary Efficacy Endpoint
Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start10 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imricor Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543798
- Sponsor's protocol ID
- VISABL-VT
- Acronym
- VISABL-VT
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05543798
- Acronym / sponsor ID
- VISABL-VT / VISABL-VT
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Imricor Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Randomized | Experimental | Device: Vision-MR Ablation Catheter 2.0All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision-MR Ablation Catheter 2.0Catheter ablation of ventricular tachycardia | Device | Non-Randomized |
Primary outcome
Primary Efficacy Endpoint
Time frame: Perioperative/Periprocedural
Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0
Primary Safety Endpoint
Time frame: 7 days
Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
1 secondary outcome
Secondary Efficacy Endpoint
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision-MR Ablation Catheter 2.0 in people with Ventricular Tachycardia, run by Imricor Medical Systems at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Lindborg, Phd (9528188400, kate.lindborg@imricor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: Perioperative/Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.