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IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry

Sponsor
University of California, Los Angeles (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04520347
Collaborator
(none)
10,000
Enrollment
42
Locations
107
Anticipated Duration (Months)
238.1
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular Contractions (PVC). The registry will be used for clinical monitoring, research, and quality improvement purposes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sudden cardiac death (SCD), predominantly due to ventricular tachyarrhythmias, is a leading cause of mortality in the United States and around the world. Catheter ablation of ventricular arrhythmias has proven efficacious in reducing the burden of arrhythmias and reducing implantable cardiac defibrillator (ICD) shocks.

    The aim of this study is to create a prospective international database registry that will allow for better assessment of the outcomes of catheter ablation of ventricular arrhythmias. The registry, with approximately 30 participating centers, will help to identify the overall success rates and associated benefits of the procedure and provide more comprehensive data on understudied populations and treatment.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry
    Actual Study Start Date :
    Dec 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Nov 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Ventricular tachycardia (VT) recurrence [From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years.]

      Freedom from ventricular tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing) or repeat procedure.

    Secondary Outcome Measures

    1. Rate of complications [From date of procedure assessed up to 12 months.]

      Cardiovascular-related and procedure-related major complications and/or adverse events.

    2. Time to transplant or death [From date of procedure assessed by date of transplant and/or death, up to 10 years.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Health, University of Arizona Medical Center Phoenix Arizona United States 85719
    2 Cedars-Sinai Medical Center Los Angeles California United States 90048
    3 University of California, Los Angeles Los Angeles California United States 90095
    4 University of California, Davis Sacramento California United States 95817
    5 University of California San Francisco San Francisco California United States 94143
    6 University of Colorado Hospital Aurora Colorado United States 80045
    7 Hartford HealthCare Hartford Connecticut United States 06103
    8 University of Florida Health Gainesville Florida United States 32610
    9 University of Chicago Medical Center Chicago Illinois United States 60637
    10 The Kansas City Heart Rhythm Institute Kansas City Kansas United States 66211
    11 University of Maryland Medical Center Baltimore Maryland United States 21201
    12 Johns Hopkins Heart and Vascular Institute Baltimore Maryland United States 21287
    13 Boston Children's Hospital Boston Massachusetts United States 02115
    14 Brigham and Women's Hospital Boston Massachusetts United States 02115
    15 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    16 UMass Memorial Health Care Worcester Massachusetts United States 01655
    17 University of Michigan Frankel Cardiovascular Center Ann Arbor Michigan United States 48109
    18 University of Minnesota VA Medical Center Minneapolis Minnesota United States 55417
    19 Mayo Clinic Rochester Minnesota United States 55902
    20 Washington University in St. Louis Saint Louis Missouri United States 63130
    21 Montefiore Medical Center Bronx New York United States 10461
    22 The Mount Sinai Hospital New York New York United States 10029
    23 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    24 Oregon Health & Science University Portland Oregon United States 97239
    25 Children's Hospital of Pennsylvania Philadelphia Pennsylvania United States 19104
    26 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    27 Medical University of South Carolina Charleston South Carolina United States 29425
    28 Vanderbilt Heart and Vascular Institute Nashville Tennessee United States 37232
    29 Texas Cardiac Arrhythmia Institute at St. David's Medical Center Austin Texas United States 78705
    30 Houston Methodist Hospital Houston Texas United States 77030
    31 University of Utah Health Salt Lake City Utah United States 84132
    32 University of Virginia Health System Charlottesville Virginia United States 22903
    33 University of Washington Medical Center Seattle Washington United States 98195
    34 The Montreal Heart Institute Montréal Canada
    35 Shaare Zedek Medical Center Jerusalem Israel
    36 Monzino Cardiology Center, University of Milan Milan Italy
    37 San Raffaele Hospital Milan Italy
    38 Dokkyo Medical University Koshigaya Hospital Koshigaya Japan
    39 Leiden University Leiden Netherlands
    40 Erasmus Medical Center Rotterdam Netherlands
    41 Gregorio Marañón General University Hospital Madrid Spain
    42 St. George's Hospital Wandsworth United Kingdom

    Sponsors and Collaborators

    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Jason Bradfield, MD, University of California, Los Angeles
    • Study Chair: Kalyanam Shivkumar, MD, PhD, University of California, Los Angeles
    • Study Chair: Paolo Della Bella, MD, San Raffaele Hospital, Italy
    • Study Chair: Francis Marchlinski, MD, FACC, FAHA, FHRS, University of Pennsylvania Health System
    • Study Chair: Andrea Natale, MD, FACC, FHRS, FESC, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
    • Study Chair: William G Stevenson, MD, Vanderbilt Heart and Vascular Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Bradfield, MD, Director, Specialized Program for Ventricular Tachycardia, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT04520347
    Other Study ID Numbers:
    • 17-001725
    First Posted:
    Aug 20, 2020
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jason Bradfield, MD, Director, Specialized Program for Ventricular Tachycardia, University of California, Los Angeles
    Arrhythmia
    Cardiac Conduction System Disease
    Sudden Cardiac Death
    Implantable Cardiac Defibrillator (ICD)
    Additional relevant MeSH terms:
    Cardiomyopathies
    Arrhythmias, Cardiac
    Tachycardia
    Tachycardia, Ventricular
    Ventricular Premature Complexes

    Study Results

    No Results Posted as of Apr 1, 2021