Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]
Charite University, Berlin, Germany
7 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
Summary
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Eligibility
Inclusion Criteria8
- Age ≥ 18 years
- Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm)
- 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)
- Written informed consent provided by study subjects obtained before any research-related test is performed
Exclusion Criteria22
- 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
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Interventions
The autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention/Reference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05809856