Clinical trials: Heart Defects, Congenital
Patent Foramen Ovale
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.
- Trial name
- PFO (NCT02882815)
- Testing
- IrisFIT PFO Occluder
- Where
- 3 sites in Germany, Ireland
- Volunteers
- 85 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Growth Failure, Congenital Heart Disease
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
This study is a prospective, open-label, multi-site, growth, safety and tolerance study to evaluate a NF (New Formula). A minimum of 45 evaluable infants with confirmed growth failure will be enrolled.
- Trial name
- NCT03563391
- Testing
- New Infant Formula
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nutricia North America
Congenital Heart Disease
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
- Trial name
- NCT00538785
- Testing
- Motavizumab, Palivizumab
- Where
- 152 sites in United States, Austria and 15 more
- Volunteers
- 1,236 people
- Sponsor
- MedImmune LLC
Congenital Heart Disease, Cardiac Anomaly
Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical…
- Trial name
- Retro-C (NCT05314868)
- Testing
- PhotoFix
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Artivion Inc.
Heart Failure, Dilated Cardiomyopathy
A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with…
- Trial name
- AUGMENT-HF (NCT01311791)
- Testing
- Algisyl-LVR, Standard medical therapy
- Where
- 18 sites in Australia, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- LoneStar Heart, Inc.
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Syncope, Pediatric
Pediatric Adhesion and New Dermal Approach Study
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease
- Trial name
- PANDA (NCT07118124)
- Testing
- Zio monitor
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- iRhythm Technologies, Inc.
Down Syndrome, Edwards Syndrome
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02787486
- Testing
- Blood sampling for Laboratory Developed Test (LDT) analysis
- Where
- 8 sites in United States
- Volunteers
- 760 people
- Sponsor
- Progenity, Inc.
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
NA-Study Withdrawn
Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
Study no longer required
- Trial name
- NCT00411658
- Testing
- Investigational Device, Experimental, Cryopreserved
- Sponsor
- LifeNet Health
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Fabry Disease
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip infusion in participants with cardiac Fabry…
- Trial name
- NCT00140621
- Testing
- Agalsidase beta
- Where
- 7 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Genzyme, a Sanofi Company
Turner Syndrome
A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and…
- Trial name
- NCT03189160
- Testing
- PEG-rhGH low dose, PEG-rhGH high dose, Non-treatment control group
- Where
- 9 sites in China
- Volunteers
- 180 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Cryptogenic Stroke
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent…
- Trial name
- NCT00465270
- Testing
- AMPLATZER PFO Occluder, Standard of Care - Medical Management
- Where
- 69 sites in United States, Canada
- Volunteers
- 980 people
- Sponsor
- Abbott Medical Devices
Pulmonary Arterial Hypertension
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
- Trial name
- MAESTRO (NCT01743001)
- Testing
- Macitentan 10 mg
- Where
- 55 sites in United States, Austria and 19 more
- Volunteers
- 226 people
- Sponsor
- Actelion
Genetic Disorder, Noonan Syndrome
Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the…
- Trial name
- NCT01529944
- Testing
- somatropin
- Where
- Sweden
- Volunteers
- 22 people
- Sponsor
- Novo Nordisk A/S
Artery, Deformity
Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)
The CT examination on IQon Spectral CT would be a standard of care CT performed as per the clinical indication. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.
- Conditions
- Artery, Deformity, Coronary (Acquired)
- Trial name
- NCT02747095
- Testing
- IQon Spectral CT
- Where
- Netherlands
- Volunteers
- 980 people
- Sponsor
- Philips Healthcare
Patent Foramen Ovale, Stroke
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO…
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Trial name
- NCT00201461
- Testing
- STARFlex septal closure system, Best medical therapy
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- NMT Medical
Intracardiac and Septal Defects, Valve and Anulus Repair
Prospective and Non-randomized Registry of CardioCel 3D
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of…
- Conditions
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction
- Trial name
- NCT04175327
- Testing
- CardioCel implantation
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 200 people
- Sponsor
- LeMaitre Vascular