Improving mapping techniques for heart rhythm disorder treatment
Optimised Decrement Evoked Potential (DeEP) Mapping to Guide Ventricular Tachycardia (VT) Ablation in Patients With Structural Heart Disease VT
NA · University Hospitals Coventry and Warwickshire NHS Trust · NCT06937983
This study is testing a new mapping technique to help doctors better find and treat the heart areas causing dangerous heart rhythms in patients with structural heart disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Coventry and Warwickshire NHS Trust (other) |
| Locations | 1 site (Coventry, West Midlands) |
| Trial ID | NCT06937983 on ClinicalTrials.gov |
What this trial studies
This study focuses on enhancing the identification of diseased heart areas responsible for ventricular tachycardia (VT) episodes in patients with structural heart disease. It utilizes a novel method called Optimised Decrement Evoked Potential (DeEP) mapping to guide catheter ablation, a minimally-invasive procedure aimed at preventing VT recurrence. By improving the mapping techniques, the study seeks to increase the effectiveness of ablation procedures, which currently face challenges in accurately locating the problematic areas in the heart. The study involves patients who have implantable cardiac defibrillators and are eligible for VT ablation as part of their standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with an implantable cardioverter defibrillator and structural heart disease eligible for VT ablation.
Not a fit: Patients with severe heart failure, life expectancy under 12 months, or those with certain cardiac devices or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of life-threatening VT episodes in patients with structural heart disease.
How similar studies have performed: While there have been various methods for mapping in VT ablation, this specific approach using Optimised DeEP mapping is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old * Patients with cardiac implantable electronic devices (CIED) (e.g. pacemakers, cardiac resynchronisation therapy (CRT) devices, implantable cardioverter defibrillator (ICD) devices) * Eligible for VT ablation as part of standard care (urgent or elective) * Ischaemic heart disease and prior myocardial infarction (MI) (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) OR other structural heart disease (such as: arrhythmogenic cardiomyopathy (ACM), or dilated cardiomyopathy (DCM), or hypertrophic cardiomyopathy (HCM), or sarcoidosis, or myocarditis). * Catheter ablation of VT ablation using Abbott intracardiac mapping catheter and Ensite intracardiac mapping system. Exclusion Criteria: * Lacks capacity to provide informed consent * New York Heart Association (NYHA) class IV heart failure * Life expectancy of less than 12 months * Implanted with a ventricular assist device * Presence of mobile intracardiac thrombus * Reversible cause of VT * Women who are pregnant or nursing * Both mechanical aortic and mitral valves * Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem the patient inappropriate to participate in this study.
Where this trial is running
Coventry, West Midlands
- University Hospitals Coventry & Warwickshire NHS Trust — Coventry, West Midlands, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Shivam Joshi
- Email: optodeepstudyoffice@uhcw.nhs.uk
- Phone: +442476966907
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.
Conditions: Structural Heart Disease, Ventricular Tachycardia, Decrementing Evoked Potential mapping, Optimisation parameters, Clinical Applicability