NL-OMON56447
Recruiting
Not Applicable
oninvasive electrocardiographic imaging for individuals at risk for apparently idiopathic ventricular fibrillation - VIGILANCE
Medisch Universitair Ziekenhuis Maastricht0 sites550 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic ventricular fibrillation
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 550
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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, as already approved in METC protocol NL32128\.068\.11 (ABR
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.
- •\- Any serious medical condition, which in the opinion of the investigator, may
- •adversely affect the safety and/or effectiveness of the participant or the
- •\- Pregnancy, nursing or planning to be pregnant.
- •\- Subject has an estimated glomerular filtration rate (eGFR) of
- •\<30mL/min/1\.73m2, using the MDRD calculation.
- •\- Unability to give informed consent.
- •\- Family members of a patients with idiopathic unexplained polymorphic VT/VF ,
Outcomes
Primary Outcomes
Not specified
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