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

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ClinicalTrials.gov Identifier: NCT04520347
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Bradfield, MD, University of California, Los Angeles

Tracking Information
First Submitted Date July 10, 2020
First Posted Date August 20, 2020
Last Update Posted Date April 1, 2021
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2020)
  • 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.
  • Time to transplant or death [ Time Frame: From date of procedure assessed by date of transplant and/or death, up to 10 years. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry
Official Title An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with ventricular arrhythmias that undergo catheter ablation for ventricular tachycardia or premature ventricular contractions.
Condition
  • Ventricular Arrhythmia
  • Ventricular Tachycardia
  • Premature Ventricular Contraction (PVC)
  • Cardiomyopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 17, 2020)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2027
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Israel,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number NCT04520347
Other Study ID Numbers 17-001725
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jason Bradfield, MD, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators Not Provided
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
PRS Account University of California, Los Angeles
Verification Date March 2021