Clinical trial NCT04520347: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventricular Arrhythmia
Ventricular Tachycardia
Premature Ventricular Contraction (PVC)
Cardiomyopathy
Keywords: Arrhythmia
Cardiac Conduction System Disease
Sudden Cardiac Death
Implantable Cardiac Defibrillator (ICD)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ventricular arrhythmias that undergo catheter ablation for ventricular tachycardia or premature ventricular contractions.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Ventricular tachycardia (VT) recurrence
timeFrame: From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years.
Secondary outcomes:
measure: Rate of complications
timeFrame: From date of procedure assessed up to 12 months.
measure: Time to transplant or death
timeFrame: From date of procedure assessed by date of transplant and/or death, up to 10 years.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health, University of Arizona Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Hartford
country: United States
facility: Hartford HealthCare
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Kansas City
country: United States
facility: The Kansas City Heart Rhythm Institute
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Heart and Vascular Institute
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Health Care
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Frankel Cardiovascular Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota VA Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: York
country: United States
facility: Wellspan Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute at St. David's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Montréal
country: Canada
facility: The Montreal Heart Institute
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Koshigaya Hospital
city: Leiden
country: Netherlands
facility: Leiden University
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Madrid
country: Spain
facility: Gregorio Marañón General University Hospital
city: Wandsworth
country: United Kingdom
facility: St. George's Hospital
Study officials:
affiliation: University of California, Los Angeles
name: Jason Bradfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Kalyanam Shivkumar, MD, PhD
role: STUDY_CHAIR
affiliation: San Raffaele Hospital, Italy
name: Paolo Della Bella, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania Health System
name: Francis Marchlinski, MD, FACC, FAHA, FHRS
role: STUDY_CHAIR
affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center
name: Andrea Natale, MD, FACC, FHRS, FESC
role: STUDY_CHAIR
affiliation: Vanderbilt Heart and Vascular Institute
name: William G Stevenson, MD
role: STUDY_CHAIR
References: