NCT05543798

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Apr 2025Jun 2027

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

September 14, 2022

Last Update Submit

January 6, 2026

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint

    Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0

    Perioperative/Periprocedural

  • Primary Safety Endpoint

    Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure

    7 days

Secondary Outcomes (1)

  • Secondary Efficacy Endpoint

    6 months

Study Arms (1)

Non-Randomized

EXPERIMENTAL

All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0

Device: Vision-MR Ablation Catheter 2.0

Interventions

Vision-MR Ablation Catheter 2.0DEVICE

Catheter ablation of ventricular tachycardia

Non-Randomized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older

You may not qualify 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

HagaZiekenhuis

The Hague, 2545 AA, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kate Lindborg, Phd

CONTACT

9528188400kate.lindborg@imricor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

April 10, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)DE(1)