Outcomes of Functional Substrate Mapping of Ventricular Tachycardia
VTFM
1 other identifier
observational
70
4 countries
8
Brief Summary
The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Typical duration for all trials
8 active sites
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 Start
First participant enrolled
July 13, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 12, 2024
January 1, 2024
2.4 years
January 23, 2023
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of cardiovascular mortality and ICD therapy
Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy
12 months
Secondary Outcomes (2)
Length of hospital stay
1 month
Left ventricular function on echocardiogram
6 months
Eligibility Criteria
Hospital
You may qualify if:
- One of the following VT events (within the last 6 months) + Ejection Fraction \<40%:
- A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic.
- B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD.
You may not qualify if:
- Contraindication to VT ablation
- Renal failure (CrCl \< 15 mL/min)
- NYHA IV or CCS IV angina
- STEMI within 1 month
- CABG within 3 months
- PCI within 1 month
- Pregnant
- Life expectancy \< 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mid and South Essex NHS Foundation Trustlead
- Abbottcollaborator
Study Sites (8)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Onassis Cardiac Surgery Center
Athens, Greece
Virgen de las Nieves University Hospital
Granada, Spain
Arrhythmia Unit, University Hospital Ramón y Cajal
Madrid, Spain
Basildon University Hospital
Basildon, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Royal Brompton & Harefield hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Srinvasan, MBBS
Mid and South Essex NHS FT
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
February 1, 2023
Study Start
July 13, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 12, 2024
Record last verified: 2024-01