Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT07026695
Eligibility Criteria:
PVC Cohort
Inclusion Criteria:
* Age \> 18 years old.
* Participants must understand and be willing to sign a written informed consent document.
* PVC burden of \>10% in a 24-hour period on Holter monitoring.
Exclusion Criteria:
* Coronary artery disease
* Known cardiac disease (heart failure or cardiomyopathy) in the documented absence of PVCs. Individuals with suspected PVC-induced cardiomyopathy heart failure, defined as cardiomyopathy or heart failure only diagnosed in the setting of a \>10% PVC burden, will be allowed to participate.
* A known diagnosis of Epilepsy.
* Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
* Participants using a TENS device for any indication
VT cohort
Inclusion Criteria:
* Participants with structural heart disease and a transvenous implantable cardioverter defibrillator (ICD) in situ
* At least three clinically significant VT events (VT events defined as either \>30 seconds of sustained VT, appropriate ICD ATP therapies or appropriate ICD shocks) in the six months before enrolment
Exclusion Criteria:
* Heart failure syndrome with inotrope dependency or requiring mechanical assistance.
* Reversible cause of arrhythmia (e.g. culprit electrolyte abnormality or toxin)
* NYHA (New York Heart Association) stage IV heart failure
* Myocardial infarction or cardiac surgery in the last six months
* Life expectancy \<12 months
* Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
* Participants using a TENS device for any indication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07026695
Study Brief:
Protocol Section:
NCT07026695