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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05809856
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm)
3. Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging:
* For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR mean systolic gradient across PV or RVOT ≥ 35 mmHg
* For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and/or mean PV or RVOT systolic gradient ≥ 40 mmHg
* Right ventricular ejection fraction (RV-EF): \<40%.
* Right ventricular end-diastolic volume (RVEDV): \>150 ml/m2 (body surface area)
4. Written informed consent provided by study subjects obtained before any research-related test is performed
Exclusion Criteria:
* Active endocarditis or myocarditis or within 3 months before the screening date
* Patients unwilling or unable to provide written informed consent or comply with follow-up requirements
* Obstruction of the central veins (including the superior and inferior vena cava, and bilateral iliac veins) such that the Ensemble-delivery system/ Performer™ - Guiding Sheath/ Extra Large Check-Flo® or GORE® DrySeal Flex + Ballon-in-Ballon-catheter cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular
* Requires emergency surgery
* Recipient of transplanted organs or currently an organ transplant candidate
* Pulmonary hypertension
* Connective tissue disorders
* Coronary artery disease
* Immunosuppressive disease
* Estimated survival of less than 6 months
* Fertile females unable to take adequate contraceptive precautions (PEARL- Index \< 1%)
* Females who are pregnant, or are currently breastfeeding an infant
* Acute myocardial infarction within 30 days of the screening date
* Stroke confirmed by CT, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before the screening date
* Hemodynamic or respiratory instability requiring inotropic or/and mechanical circulatory support, or mechanical ventilation within 30 days before the screening date
* Severe left ventricular systolic dysfunction with ejection fraction ≤ 20% or evidence of an intra-cardiac mass, thrombus, or vegetation assessed by echocardiography before the screening date
* Renal insufficiency with creatinine level 2.5 mg/dl within 60 days before the screening date
* Leukopenia with WBC \<3.5 x 109/L anemia with Hgb \<10 g/dl, or thrombocytopenia with platelet count \<50x103/l accompanied by a history of bleeding diathesis or coagulopathy within 60 days before the screening date
* Adult subject is an illicit drug user, alcohol abuser, or unable to give informed consent
* Subject is institutionalized by court order or by order of authority (e.g. prisoner, untreated psychiatry; limited compliance)
* Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than six months Inability to comply with all of the study procedures and follow-up visits
* Subjects who are dependent on the sponsor or investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05809856
Study Brief:
Protocol Section:
NCT05809856