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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.


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Study Design


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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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