GrOwnValve - novel heart valve replacement approach: 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).
Study summary
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Death — Up to 5 Years Follow-Up (valve-related, sudden, cardiac, and all-cause death)
Major bleeding — Up to 1 Year Follow-Up Assessment if device-related major bleeding has occured by laboratory + echo + CT
Reoperation — Up to 5 Years Follow-Up Questioning if device-related re-operation occured
Acute device-related complications — Up to 5 Years Follow-Up Measurement tool: Spiroergometry
o Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Oxygen supply — Up to 5 Years Follow-Up Measurement tool: Spiroergometry Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Valve opening and closure behavior — Up to 5 Years Follow-Up Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) blood flow velocity / stenosis, 2.) stiff leaflet, 3.) valve opening area Decision rule: blood flow velocity \>4 m/s, abnormal or no leaflet motion when compared to neighboring leaflets, \> 0.70 for 17 diameter, \> 0.85 for 19, \> 1.05 for 21, \> 1.25 for 23, \> 1.45 for 25, \> 1.70 for 27, 1.95 for 29, and 2.25 for 31 mm annulus diameter
Valve closure behavior — Up to 5 Years Follow-Up Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) vena contracta, 2.) Proximal Isovelocity Surface Area (PISA) radius, 3.) Effective regurgitation orifice area (EROA=2π\*r2\*Va/Vmax), (iv) sagging leaflet Decision rule: 1.) less than or equal to 15% of the diameter of PA/stent at a Nyquist limit of 0.5-0.6 m/s, frame rate \>20/sec, gain adjusted, sector small, 2.) equal or minor to 4 mm at a Nyquist limit of 0.2-0.4 m/s, frame rate \>20/sec, gain adjusted, variance off, sector small, 3.) \< or equal to 3% of the total cross-sectional area of the valve, 4.) n.a
Heart rhythm — Up to 5 Years Follow-Up Assessment if new or higher grade of cardiac arrhythmia occured, i.e. newly ventricular extra systoly
Position and condition of the stent and structures — Up to 1 Year Follow-Up Measurement tool: Echocardiography + Magnetic resonance imaging + computed tomography Parameter: 1.) GrOwnValve annulus, 2.) no broken struts of the valve stent Decision rule: 1.) +/- 1.5 mm from the native pulmonary valve annulus, 2.) n.a.
Blood flow — Up to 1 Year Follow-Up Assessment of backflow and volume of blood by echo + MRI
Trial sites (1)
Facility
City
Region
Status
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité
Berlin
State of Berlin
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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