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Tests treatment safety and results for Pulmonary Valve Insufficiency
Official title Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
ClinicalTrials.gov ID: NCT05809856
What this study is testing
- What it's testing
- Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 years
- Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia...
- 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...
- For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and/or mean PV or RVOT systolic gradient...
You likely can't join 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/...
- Requires emergency surgery
- Recipient of transplanted organs or currently an organ transplant candidate
- Pulmonary hypertension
See the full eligibility criteria
- 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 people obtained before any research-related test is performed
- 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...
- 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
- people who are dependent on the sponsor or investigators
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, State of Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.