UnknownNot Applicable

Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.

Netherlands500 participantsStarted 2019-04-10

Plain-language summary

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family members and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Also a National Dutch registry for patients with unexplained polymorphic VT and/or VF and their family members will be created. By combining the data from the registry and the results of ECGI, The investigators hope to identity risk markers for patients at higher risk for apparently idiopathic ventricular fibrillation, and use these for an adapted flow chart for the 'general'population of patients at risk for unexplained polymorphic VT and/or VF. The investigators aim to be able to identify patients before the first arrhythmic event, and aim for better treatment strategies in the future.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In order to be eligible to participate in this study, a subject must be ≥ 18 years old and meet one of the following criteria: * All unexplained polymorphic VT or VF survivors in whom known structural myocardial, respiratory, metabolic and toxicological causes have been excluded through clinical evaluation", with/without a genetic mutation. NB. If results of a diagnostic tests show minor abnormalities but insufficient for a specific diagnosis, this is no exclusion criterion. * Selected family members of these patients\* * Control subjects with structurally normal hearts with a clinical indication for a cardiac CT scan. * All 1st and 2nd degree family members being in contact with the cardiologist/treating physician as part of cascade screening will be contacted as described in chapter 11.2.2. Family members must be in adequate health to be able to travel to the hospital for research purposes. 3rd degree family members can also be contacted as described in chapter 11.2.2 if at least one of the following criteria is met: * The family member has the same genetic mutation as index patient, or; * The family member has demonstrated ventricular arrhythmias, or; * The clinician has a very strong suspicion of ventricular arrhythmias in the family member. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * A known strong reaction against electrode attachment or contrast agent…

What they're measuring

ECG-Imaging outcome: epicardial potentials

Timeframe: 3 years

ECG-Imaging outcome: activation and repolarization maps

Timeframe: 3 years

Trial details

NCT IDNCT03963271

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-10