Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Recruiting

• Conditions: Ventricular Tachycardia

• Registration Number: NCT05708131
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

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.

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 Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-02-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of cardiovascular mortality and ICD therapy	12 months	Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy

Secondary Outcome Measures

Name	Time	Method
Left ventricular function on echocardiogram	6 months	Left ventricular function on echocardiogram
Length of hospital stay	1 month	Length of hospital stay

Trial Locations

Locations (8)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Royal Brompton & Harefield hospital; 🇬🇧 London, United Kingdom

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece