Clinical trials: Defects
Patent Foramen Ovale, PFO
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
- Trial name
- NCT05893758
- Testing
- The Cera™ PFO Occluder
- Where
- 5 sites in Poland
- Volunteers
- 94 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Achromatopsia
Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia (A Clarity Clinical Trial)
This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGB3 gene.
- Trial name
- NCT02599922
- Testing
- rAAV2tYF-PR1.7-hCNGB3
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Beacon Therapeutics
Osteoarthritis, Traumatic Arthritis
The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in…
- Trial name
- NCT02539069
- Testing
- Chondron Implantation
- Where
- South Korea
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
PFO - Patent Foramen Ovale
Amplatzer PFO Occluder Post-marketing Surveillance Study
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical…
- Trial name
- PFO PMS Jpn (NCT04349995)
- Testing
- Amplatzer PFO Occluder
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitochondrial Diseases, Barth Syndrome
An Intermediate Size Expanded Access Protocol of Elamipretide
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program.
- Trial name
- NCT04689360
- Testing
- elamipretide
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Defects, Congenital
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries.
- Trial name
- XEL-CR-06 (NCT02377700)
- Testing
- Xeltis Vascular Patch, Model COR-VP-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Heart Septal Defects, Atrial, Atrial Septal Defect
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
- Trial name
- NCT03601039
- Testing
- Absnow Absorbable ASD Closure System
- Where
- 14 sites in China
- Volunteers
- 165 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Traumatic Articular Cartilage Defects in the Knee Joint
Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects
In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and…
- Trial name
- N3D (NCT01656902)
- Testing
- NOVOCART® 3D plus, Microfracture
- Where
- 35 sites in Austria, Czechia and 8 more
- Volunteers
- 263 people
- Sponsor
- Tetec AG
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Down Syndrome, Patau Syndrome
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.
- Conditions
- Down Syndrome, Patau Syndrome, Edward's Syndrome
- Trial name
- TWIN (NCT03200041)
- Testing
- Blood sample
- Where
- United Kingdom
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Premaitha Health
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Cardiac Disease, Respiratory Disease
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases
- Trial name
- BRIDGE (NCT05319236)
- Testing
- Gabi System
- Where
- 4 sites in United States, Belgium
- Volunteers
- 101 people
- Sponsor
- Gabi SmartCare
Idiopathic Short Stature, Small for Gestational Age
A Trial of YPEG-rhGH in Children With Short Stature
To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for…
- Conditions
- Idiopathic Short Stature, Small for Gestational Age, Turner Syndrome
- Trial name
- NCT05838885
- Testing
- YPEG-rhGH, rhGH
- Where
- 19 sites in China
- Volunteers
- 78 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Achromatopsia
Natural History Study for Achromatopsia
In preparation for human clinical trials we intend to undertake a detailed phenotypic study to help to identify patients who may be suitable for therapeutic intervention.
- Trial name
- NCT04124185
- Testing
- Ocular assessments
- Where
- United Kingdom
- Volunteers
- 85 people
- Sponsor
- MeiraGTx UK II Ltd
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Novo Nordisk A/S