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:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT03617406
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Written informed consent
* Patients with LFLGAS (mean Gradient: \< 40 mmHg, AVA ≤ 1.0 cm2 (by continuity equation using LVOT diameter) SVI ≤ 35 ml/m2), by rest TTE
Exclusion Criteria:
* Hypersensitivity to dobutamine or midazolam
* Lack of safe contraception defined as: Female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Previous enrolment into the current study,
ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING STRESS ECHOCARDIOGRAPHY:
* Systolic left ventricular ejection fraction (LVEF) \< 20%
* More than mild aortic regurgitation
* Mitral valve disease, defined by mitral valve area \< 2.0 cm2 or more than mild mitral regurgitation
* Unstable angina
* Acute pulmonary oedema
* Signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation
* Signs of relevant right ventricular heart failure defined as central venous pressure (CVP) \> 15 mmHg estimated with dilatation and collapsibility of vena cava inferior (VCI)
* Severe pulmonary, renal or hepatic disease
ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY:
* Oesophageal varices
* History of bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03617406
Study Brief:
Protocol Section:
NCT03617406