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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03910751
Eligibility Criteria:
Inclusion Criteria:
* Eligible for ACURATE Neo valve implantation
* Patient agrees to follow-up duration
* Patient is able to understand and sign written informed consent
Exclusion Criteria:
* BMI \> 35
* Pregnancy
Cardiac
* Moderate to severely impaired left ventricular ejection fraction (LVEF \<35%)
* Mitral regurgitation \> moderate
* Pulmonary hypertension (sPAP \> 60mmHg)
* No complex coronary artery disease
* Untreated high degree AV-block or RBBB
Pulmonary
* COPD Gold \> 2
Kidney function
* GFR \< 35ml/min
Frailty
* Inappropriate social support and/or (familial) care
* Patient is walking aid dependent
TAVI strategy
* Presence of severe peripheral artery disease
* Transfemoral approach not possible
Follow up
* Inability to adhere to follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03910751
Study Brief:
Protocol Section:
NCT03910751