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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT03994068
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are at least 18 years or older
2. Subjects who are scheduled for PVC/VT ablation procedure
3. Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
4. Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
5. Subjects with or without cardiac structural disease
Exclusion Criteria:
1. Reversible causes of PVC/VT
2. Subjects with recent (within 3 months) acute coronary syndrome
3. Subjects who are contraindicated for CT or MRI (must be able to get one)
4. Subject whose MRI or CT scan does not comply with the requirements of this protocol
5. Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
* INR \> 3.5
* Active infection
* Pregnancy: Females of childbearing potential with a positive pregnancy test.
6. Existing mechanical heart valve
7. Subjects with structural cardiac disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03994068
Study Brief:
Protocol Section:
NCT03994068