Mapping the causes of ventricular tachycardia
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry
This study is testing a new ablation technique for ventricular tachycardia in people with heart disease to see if it is safer and more effective than the standard method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mid and South Essex NHS Foundation Trust Academic / other |
| Locations | 8 sites (Philadelphia, Pennsylvania and 7 other locations) |
| Trial ID | NCT05708131 on ClinicalTrials.gov |
What this trial studies
This international multicentre registry aims to evaluate the safety and effectiveness of a specific ablation technique for ventricular tachycardia (VT) in patients with ischaemic heart disease. Participants will be monitored before, during, and after the procedure, with follow-up assessments at 6 and 12 months to compare outcomes with a control group receiving standard ablation methods. The study will focus on mortality rates and the need for implantable cardioverter-defibrillator (ICD) therapies post-ablation.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of ventricular tachycardia events and an ejection fraction of less than 40%.
Not a fit: Patients with contraindications to VT ablation or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced mortality for patients with ventricular tachycardia.
How similar studies have performed: Previous studies have shown promise in similar ablation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania and 7 other locations
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Onassis Cardiac Surgery Center — Athens, Greece (Recruiting)
- Virgen de las Nieves University Hospital — Granada, Spain (Recruiting)
- Arrhythmia Unit, University Hospital Ramón y Cajal — Madrid, Spain (Recruiting)
- Basildon University Hospital — Basildon, United Kingdom (Recruiting)
- Royal Sussex County Hospital — Brighton, United Kingdom (Recruiting)
- Royal Brompton & Harefield hospital — London, United Kingdom (Recruiting)
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Neil Srinvasan, MBBS — Mid and South Essex NHS FT
- Study coordinator: Neil Srinivasan, MBBS
- Email: neil.srinivasan2@nhs.net
- Phone: +(44)1268 524900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.