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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT03024268
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Previous MitraClip implantation
* Persistent relevant iASD 30 days after MitraClip intervention
Exclusion Criteria:
* Unsuccessful MitraClip implantation
* No relevant iASD 30 days after MitraClip intervention
* Unstable angina in the previous 4 weeks
* Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy
* Constrictive pericarditis / restrictive cardiomyopathies
* Pericardial effusion planed for surgery or interventional therapy
* Coagulation disorders
* Malignant disease with a life expectance \< 12 months
* Pregnancy
* Participation in another study
* iASD diameter \> 38 mm
* Aortic minimum distance of the iASD \< 5 mm
* Thrombus in left atrial appendage
* Venous access impossible with a 24 French catheter system
* Presence of an inferior vena cava filter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03024268
Study Brief:
Protocol Section:
NCT03024268