IVTCC 2.0: a Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry

• Conditions: Cardiomyopathy; Ventricular Tachycardia; Premature Ventricular Contraction (PVC); Ventricular Arrhythmia

• Registration Number: NCT04520347
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (40)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Wellspan Health; 🇺🇸 York, Pennsylvania, United States

Banner Health, University of Arizona Medical Center; 🇺🇸 Phoenix, Arizona, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Hartford HealthCare; 🇺🇸 Hartford, Connecticut, United States

University of Florida Health; 🇺🇸 Gainesville, Florida, United States

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