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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04520347
Other study ID # 17-001725
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date November 2027

Study information

Verified date November 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10000
Est. completion date November 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs).

Study Design


Locations

Country Name City State
Canada The Montreal Heart Institute Montréal
Israel Shaare Zedek Medical Center Jerusalem
Italy Monzino Cardiology Center, University of Milan Milan
Italy San Raffaele Hospital Milan
Japan Dokkyo Medical University Koshigaya Hospital Koshigaya
Netherlands Leiden University Leiden
Netherlands Erasmus Medical Center Rotterdam
Spain Gregorio Marañón General University Hospital Madrid
United Kingdom St. George's Hospital Wandsworth
United States University of Michigan Frankel Cardiovascular Center Ann Arbor Michigan
United States University of Colorado Hospital Aurora Colorado
United States Texas Cardiac Arrhythmia Institute at St. David's Medical Center Austin Texas
United States Johns Hopkins Heart and Vascular Institute Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Children's Hospital Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Health System Charlottesville Virginia
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States University of Florida Health Gainesville Florida
United States Hartford HealthCare Hartford Connecticut
United States Houston Methodist Hospital Houston Texas
United States The Kansas City Heart Rhythm Institute Kansas City Kansas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of California, Los Angeles Los Angeles California
United States University of Minnesota VA Medical Center Minneapolis Minnesota
United States Vanderbilt Heart and Vascular Institute Nashville Tennessee
United States The Mount Sinai Hospital New York New York
United States Children's Hospital of Pennsylvania Philadelphia Pennsylvania
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States Banner Health, University of Arizona Medical Center Phoenix Arizona
United States Oregon Health & Science University Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States University of California, Davis Sacramento California
United States Washington University in St. Louis Saint Louis Missouri
United States University of Utah Health Salt Lake City Utah
United States University of California San Francisco San Francisco California
United States University of Washington Medical Center Seattle Washington
United States UMass Memorial Health Care Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventricular tachycardia (VT) recurrence 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 Rate of complications Cardiovascular-related and procedure-related major complications and/or adverse events. From date of procedure assessed up to 12 months.
Secondary Time to transplant or death From date of procedure assessed by date of transplant and/or death, up to 10 years.
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