Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve

NCT05809856 | Recruiting DMC

• 1 other identifier: 100592731
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.

Conditions

Pulmonary Valve Insufficiency

Keywords

Heart Valve Replacement; Pulmonary Valve; Congenital Heart Diseases; Transcatheter Valve; Medical Need; Durable; One-time-solution; Autologous Living Tissue

Outcome Measures

Primary Outcomes (10)

• Death

  (valve-related, sudden, cardiac, and all-cause death)

  Up to 5 Years Follow-Up

• Major bleeding

  Assessment if device-related major bleeding has occured by laboratory + echo + CT

  Up to 1 Year Follow-Up

• Reoperation

  Questioning if device-related re-operation occured

  Up to 5 Years Follow-Up

• Acute device-related complications

  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

  Up to 5 Years Follow-Up

• Oxygen supply

  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

  Up to 5 Years Follow-Up

• Valve opening and closure behavior

  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

  Up to 5 Years Follow-Up

• Valve closure behavior

  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

  Up to 5 Years Follow-Up

• Heart rhythm

  Assessment if new or higher grade of cardiac arrhythmia occured, i.e. newly ventricular extra systoly

  Up to 5 Years Follow-Up

• Position and condition of the stent and structures

  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.

  Up to 1 Year Follow-Up

• Blood flow

  Assessment of backflow and volume of blood by echo + MRI

  Up to 1 Year Follow-Up

Secondary Outcomes (7)

• Availability of pericardium or other tissue for preparation of autologous pulmonary valve graft

  Procedure (intra-operatively)

• Post-procedure length of stay

  Up to day of discharge ( ≤ 30 days)

• Ventilation time

  Procedure (intra-operatively)

• Freedom from conduction disturbances and arrhythmias need for permanent pacemaker implantation

  Up to 3 months Follow-Up

• (Re-)Hospitalization

  Up to 60 months (5 years) Follow-Up

Study Arms (1)

Implantation of autologous GrOwnValve

EXPERIMENTAL

Implantation of autologous GrOwnValve via minimal-invasive transcatheter technique into patients with high-grade pulmonary valve insufficiency and right ventricular dilatation.

Device: GrOwnValve - novel heart valve replacement approach

Interventions

GrOwnValve - novel heart valve replacement approach DEVICE

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).

Implantation of autologous GrOwnValve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• GrOwnValve GmbH: collaborator

Study Sites (1)

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Valve Insufficiency; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Boris Schmitt, Dr.

  Charité UNiveristätsmedizin Berlin, Deutsches Herzzentreum der Charité

  STUDY DIRECTOR

Central Study Contacts

Boris Schmitt, Dr.

CONTACT

+49 30 4593 2846; boris.schmitt@charite.de

Frank Edelmann, Prof. Dr.

CONTACT

+49 30 450 553731; frank.edelmann@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Model Details: Non-inferiority analysis with standard of current medical care

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: April 12, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)