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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04520347




Registration number
NCT04520347
Ethics application status
Date submitted
10/07/2020
Date registered
20/08/2020
Date last updated
28/09/2022

Titles & IDs
Public title
IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry
Scientific title
An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry
Secondary ID [1] 0 0
17-001725
Universal Trial Number (UTN)
Trial acronym
IVTCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Arrhythmia 0 0
Ventricular Tachycardia 0 0
Premature Ventricular Contraction (PVC) 0 0
Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ventricular tachycardia (VT) recurrence
Timepoint [1] 0 0
From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years.
Secondary outcome [1] 0 0
Rate of complications
Timepoint [1] 0 0
From date of procedure assessed up to 12 months.
Secondary outcome [2] 0 0
Time to transplant or death
Timepoint [2] 0 0
From date of procedure assessed by date of transplant and/or death, up to 10 years.

Eligibility
Key inclusion criteria
- All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature
ventricular contractions (PVCs).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Canada
State/province [22] 0 0
Montréal
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Italy
State/province [24] 0 0
Milan
Country [25] 0 0
Japan
State/province [25] 0 0
Koshigaya
Country [26] 0 0
Netherlands
State/province [26] 0 0
Leiden
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Wandsworth

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, Los Angeles
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04520347
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jason Bradfield, MD
Address 0 0
University of California, Los Angeles
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04520347