IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry (IVTCC)

November 9, 2023 updated by: Jason Bradfield, MD, University of California, Los Angeles

An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

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

Study Locations

  • Canada
      • Montréal, Canada
        • The Montreal Heart Institute
  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
  • Italy
      • Milan, Italy
        • San Raffaele Hospital
      • Milan, Italy
        • Monzino Cardiology Center, University of Milan
  • Japan
      • Koshigaya, Japan
        • Dokkyo Medical University Koshigaya Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leiden University
      • Rotterdam, Netherlands
        • Erasmus Medical Center
  • Spain
      • Madrid, Spain
        • Gregorio Marañón General University Hospital
  • United Kingdom
      • Wandsworth, United Kingdom
        • St. George's Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85719
        • Banner Health, University of Arizona Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06103
        • Hartford Healthcare
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health
    • Kansas
      • Kansas City, Kansas, United States, 66211
        • The Kansas City Heart Rhythm Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Heart and Vascular Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Health Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Frankel Cardiovascular Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • University of Minnesota VA Medical Center
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University in St. Louis
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Heart and Vascular Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Institute at St. David's Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University Of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with ventricular arrhythmias that undergo catheter ablation for ventricular tachycardia or premature ventricular contractions.

Description

Inclusion Criteria:

- All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular tachycardia (VT) recurrence
Time Frame: 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.
From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: From date of procedure assessed up to 12 months.
Cardiovascular-related and procedure-related major complications and/or adverse events.
From date of procedure assessed up to 12 months.
Time to transplant or death
Time Frame: From date of procedure assessed by date of transplant and/or death, up to 10 years.
From date of procedure assessed by date of transplant and/or death, up to 10 years.

Collaborators and Investigators

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

Sponsor

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 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 (Actual)

December 1, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001725

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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