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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT03585933
Eligibility Criteria:
Inclusion Criteria:
* Severe aortic stenosis (aortic valve area \<1.0cm2 or aortic valve area index \<0.6 cm2/m2
* Age ≥18 years.
* Signed informed patient consent form.
Exclusion Criteria:
* Severe valvular disease other than AS.
* Significant coronary heart disease requiring revascularisation.
* History of myocardial infarction.
* Previous cardiac surgery.
* Severe renal impairment eGFR \<30ml/min/1.73m2.
* Any absolute contraindication to CMR.
* Inherited or acquired cardiomyopathy.
* Other medical conditions that limits life expectancy or precludes SAVR or TAVI.
* Pregnant or nursing women
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
* Patients in permanent atrial fibrillation.
* Significant chronic obstructive pulmonary disease (FEV1 \<70% of predicted value)
* Patient with implanted devices (pacemaker, ICD)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03585933
Study Brief:
Protocol Section:
NCT03585933