NCT04520347

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
7 countries

41 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Dec 2018Nov 2027

Study Start

First participant enrolled

December 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

8 years

First QC Date

July 10, 2020

Last Update Submit

December 8, 2025

Conditions

Keywords

ArrhythmiaCardiac Conduction System DiseaseSudden Cardiac DeathImplantable Cardiac Defibrillator (ICD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rate of complications

    From date of procedure assessed up to 12 months.

  • Time to transplant or death

    From date of procedure assessed by date of transplant and/or death, up to 10 years.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ventricular arrhythmias that undergo catheter ablation for ventricular tachycardia or premature ventricular contractions.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Banner Health, University of Arizona Medical Center

Phoenix, Arizona, 85719, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Hartford HealthCare

Hartford, Connecticut, 06103, United States

Location

University of Florida Health

Gainesville, Florida, 32610, United States

Location

The Kansas City Heart Rhythm Institute

Kansas City, Kansas, 66211, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Heart and Vascular Institute

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Health Care

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Frankel Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Wellspan Health

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Austin, Texas, 78705, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

The Montreal Heart Institute

Montreal, Canada

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Dokkyo Medical University Koshigaya Hospital

Koshigaya, Japan

Location

Leiden University

Leiden, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Gregorio Marañón General University Hospital

Madrid, Spain

Location

St. George's Hospital

Wandsworth, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Premature ComplexesCardiomyopathiesArrhythmias, CardiacCardiac Conduction System DiseaseDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

TachycardiaHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Complexes, PrematureHeart ArrestDeath, SuddenDeath

Study Officials

  • Jason Bradfield, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Specialized Program for Ventricular Tachycardia

Study Record Dates

First Submitted

July 10, 2020

First Posted

August 20, 2020

Study Start

December 1, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations