VTFM: Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Sponsor

Mid and South Essex NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05708131

Collaborator

Abbott (Industry)

Enrollment

Locations

28.6

Anticipated Duration (Months)

8.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

70 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 13, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Composite of cardiovascular mortality and ICD therapy [12 months]
Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy

Secondary Outcome Measures

Length of hospital stay [1 month]
Length of hospital stay
Left ventricular function on echocardiogram [6 months]
Left ventricular function on echocardiogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Onassis Cardiac Surgery Center	Athens		Greece
3	Virgen de las Nieves University Hospital	Granada		Spain
4	Arrhythmia Unit, University Hospital Ramón y Cajal	Madrid		Spain
5	Basildon University Hospital	Basildon		United Kingdom
6	Royal Sussex County Hospital	Brighton		United Kingdom
7	Royal Brompton & Harefield hospital	London		United Kingdom
8	St Bartholomew's Hospital	London		United Kingdom

Sponsors and Collaborators

Mid and South Essex NHS Foundation Trust
Abbott

Investigators

Principal Investigator: Neil Srinvasan, MBBS, Mid and South Essex NHS FT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mid and South Essex NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT05708131

Other Study ID Numbers:

315453

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of Feb 8, 2023