Non-invasive mapping to help treat ventricular tachycardia due to heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the VIVO non-invasive mapping system to guide catheter ablation for ventricular tachycardia in patients with structural heart disease following a myocardial infarction. Eligible participants are adults with prior ICD therapy or shocks/ATP episodes, recent cardiac imaging, and suitability for standard VT ablation. The approach aims to streamline the ablation procedure by mapping the VT substrate non-invasively before invasive ablation. The study requires participants to undergo follow-up visits for at least six months after enrollment. Outcomes will assess procedural efficiency, safety, and VT recurrence, comparing non-invasive mapping-guided ablation to conventional approaches in routine NHS care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years old
* Patient with the following:

  * Evidence of post-myocardial infarction\* structural heart disease.
  * Cardiac CT and/or cardiac MRI scan performed within 6 months.
  * ICD/CRTD implantation.
  * Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.
* Suitable candidate for VT ablation as per NHS standard of care.
* Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.

Exclusion Criteria:

* Lacks capacity to provide informed consent.
* Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
* Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
* Sepsis, active systemic infection or fever (\>100.5 F/38 C) within a week prior to the ablation procedure.
* Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
* Known allergies or intolerance to AADs to be used to treat PVCs.
* Known allergy for contrast.
* Female patients who are pregnant or breast feeding.
* Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem them inappropriate to participate in this study.
* Other conditions that may prevent patients from adhering to the study protocol, in the opinion of the investigator.

Where it's running

• University Hospitals Coventry and Warwickshire
  Coventry, United Kingdom Recruiting
• The James Cook University Hospital
  Middlesbrough, United Kingdom Recruiting
• Royal Sussex County Hospital
  Brighton, United Kingdom Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Severe Complications During VT/PVC Ablation

  This study looks at real-world cases to see what severe complications occur during VT or PVC ablations and how patients are managed afterward.

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• Personalised VT substrate mapping with dynamic voltage mapping during ablation

  A procedure study to see if using dynamic voltage mapping during VT ablation helps identify and treat scar-related electrical circuits in people with ventricular tachycardia.

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• Catheter ablation plus LAAC vs anticoagulation in frail elderly A-fib patients

  This study tests whether adding left atrial appendage closure to ablation is as good as using long-term blood thinners in frail people aged 75 and up with atrial fibrillation.

  Recruiting Guangdong Provincial People's Hospital · Guangzhou, Guangdong · NCT07441382

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.