Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (VTFM)

Mid and South Essex NHS Foundation Trust

Status: Enrolling

Conditions: Ventricular Tachycardia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05708131

315453

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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