Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05708131

Acronym

VTFM

Enrollment

Registered

2023-02-01

Start date

2022-07-13

Completion date

2024-12-01

Last updated

2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Composite of cardiovascular mortality and ICD therapy	12 months	Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy

Secondary

Measure	Time frame	Description
Length of hospital stay	1 month	Length of hospital stay
Left ventricular function on echocardiogram	6 months	Left ventricular function on echocardiogram

Countries

Greece, Spain, United Kingdom, United States

Contacts

Primary ContactNeil Srinivasan, MBBS

neil.srinivasan2@nhs.net+(44)1268 524900

Backup ContactFatima Bangash, MBBS

Fatima.bangash4@nhs.net

Outcome results