Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— VTFM  

Official title:

Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708131
• Other study ID #: 315453
• Status: Recruiting
• Start date: July 13, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Mid and South Essex NHS Foundation Trust
• Contact: Neil Srinivasan, MBBS
• Phone: +(44)1268 524900
• Email: neil.srinivasan2[@]nhs.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Center	Athens
Spain	Virgen de las Nieves University Hospital	Granada
Spain	Arrhythmia Unit, University Hospital Ramón y Cajal	Madrid
United Kingdom	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 States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Abbott

Countries where clinical trial is conducted

United States,  Greece,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiovascular mortality and ICD therapy	Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy	12 months
Secondary	Length of hospital stay	Length of hospital stay	1 month
Secondary	Left ventricular function on echocardiogram	Left ventricular function on echocardiogram	6 months