Clincosm LogoSign in Get a demo

Parallel Mapping for Ventricular Tachycardia

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04477499
Collaborator
Biosense Webster, Inc. (Industry)
30
Enrollment
1
Location
29.5
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping
    Actual Study Start Date :
    Jul 15, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Single procedure freedom from ventricular recurrence at 1 year [12 months]

      Number of VT

    Secondary Outcome Measures

    1. Freedom from implantable cardioverter defibrillator (ICD) shocks [12 months]

      Number of ICD shocks

    2. Reduction in mapping time using parallel mapping algorithm [12 months]

      Minutes

    3. Reduction in radiofrequency ablation time [12 months]

      Minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years

    • History of scar-mediated sustained ventricular tachycardia

    • Failure of therapy with Anti arrhythmic drugs

    • Implanted ICD or a plan for ICD implantation after the ablation

    • Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements

    • Ability to understand the requirements of the study and sign an informed consent

    Exclusion Criteria:

    • Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities

    • Contraindication to anticoagulation therapy

    • Stroke within 30 days before enrollment

    • Life expectancy <1 year

    • Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements

    • Pregnant or breast feeding at time of signing consent

    • Patient undergoing cardiac transplantation

    • Enrolled or participates in other drug or device studies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic
    • Biosense Webster, Inc.

    Investigators

    • Principal Investigator: Jakub Sroubek, MD, PhD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jakub Sroubek, Principal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT04477499
    Other Study ID Numbers:
    • IRB 20-470
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tachycardia
    Tachycardia, Ventricular

    Study Results

    No Results Posted as of Jan 14, 2022