VT Ablation in the iCMR (VISABL-VT)

September 18, 2022 updated by: Imricor Medical Systems

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months
  • 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/echocardiogram 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
  • Class IV Heart Failure
  • Ejection Fraction (EF) < 25%
  • Patients with a glomerular filtration rate (GFR) < 30
  • Women who are pregnant
  • Life expectancy < 12 months
  • Enrollment in another study without sponsor approval

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Randomized
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
Catheter ablation of ventricular tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 30 minutes post procedure
Acute success defined as absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the investigational device.
30 minutes post procedure
Primary Safety Endpoint
Time Frame: 7 days
Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Endpoint
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imricor Medical Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISABL-VT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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