IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry

Ventricular Tachycardia Clinical Trial

— IVTCC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04520347
• Other study ID #: 17-001725
• Status: Enrolling by invitation
• 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
• 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).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Cardiomyopathy
• Premature Ventricular Contraction (PVC)
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrhythmia
• Ventricular Premature Complexes
• Ventricular Tachycardia

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.