Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Last updated: January 11, 2024
Sponsor: Mid and South Essex NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Disease

Heart Defect

Treatment

N/A

Clinical Study ID

NCT05708131
315453
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 issymptomatic. B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below thedetection rate of the ICD.

Exclusion

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

Total Participants: 70
Study Start date:
July 13, 2022
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Onassis Cardiac Surgery Center

    Athens,
    Greece

    Active - Recruiting

  • Virgen de las Nieves University Hospital

    Granada,
    Spain

    Active - Recruiting

  • Arrhythmia Unit, University Hospital Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Basildon University Hospital

    Basildon,
    United Kingdom

    Active - Recruiting

  • Royal Sussex County Hospital

    Brighton,
    United Kingdom

    Active - Recruiting

  • Royal Brompton & Harefield hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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