Clinical trials: Cardiac Defect
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.
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Defect
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple.
- Trial name
- NCT02658266
- Testing
- Home based resistance training
- Where
- 3 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Umeå University
Ventricular Dysfunction, Pericardial Effusion
Focused Cardiac Ultrasound
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
- Conditions
- Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect
- Trial name
- NCT03887286
- Testing
- Philips EPIQ 7 ultrasound machine, Philips Lumify Broadband sector array transducer
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- University of Miami
Congenital Heart Disease (CHD), Congenital Heart Defect
Clinical Readiness Skin Punch Biopsy Sample Collections
This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
- Trial name
- NCT06588426
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- HeartWorks, Inc.
Mitral Valve Insufficiency, Heart Septal Defects, Atrial
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.
- Trial name
- NCT03024268
- Testing
- Figulla Flex Occluder (Occlutech)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Heart Center Leipzig - University Hospital
Atrial Septal Defect
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each).
- Trial name
- NCT04096924
- Testing
- Guidewire for echo-guided interventions, Cook lunderquist guidewire
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
Double Outlet Right Ventricle, Transposition of the Great Arteries
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images…
- Conditions
- Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries
- Trial name
- NCT04788082
- Testing
- 3D Printed Heart Model
- Where
- 3 sites in United States
- Sponsor
- Children's National Research Institute
Congenital Heart Disease, Congenital Heart Defect
Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery.
- Conditions
- Congenital Heart Disease, Congenital Heart Defect, Congenital Heart Malformations
- Trial name
- NCT05101746
- Testing
- Nitric Oxide (NO) 20 part per million (ppm), Standard of care cardiopulmonary bypass
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Vanderbilt University Medical Center
DiGeorge Syndrome, Shprintzen Syndrome
Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
OBJECTIVES: I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due to DiGeorge syndrome or velocardiofacial syndrome. II.
- Conditions
- DiGeorge Syndrome, Shprintzen Syndrome, Chromosome Abnormalities, Abnormalities, Multiple
- Trial name
- NCT00005102
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Center for Research Resources (NCRR)
Mitral Regurgitation
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve.
- Trial name
- DGS-M3 (NCT07878195)
- Where
- Austria
- Volunteers
- 77 people
- Sponsor
- Medical University of Vienna
Congenital Heart Defects, VSD
Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve…
- Trial name
- ABSORB-VSD (NCT07040579)
- Testing
- transcatheter closure of outlet VSDs with bioabsorbable occluders
- Where
- China
- Volunteers
- 50 people
- Sponsor
- First Affiliated Hospital of Guangxi Medical University
Neonatal Respiratory Failure, Congenital Heart Defect
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming.
- Trial name
- NCT03154112
- Testing
- Measurement of oxygen consumption and caloric expenditure
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Boston Children's Hospital
Transposition of the Great Arteries, Tetralogy of Fallot
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery…
- Conditions
- Transposition of the Great Arteries, Tetralogy of Fallot, Ventricular Septal Defect
- Trial name
- NCT01915277
- Testing
- Dexmedetomidine
- Where
- 4 sites in United States
- Volunteers
- 119 people
- Sponsor
- Carelon Research
Atrial Fibrillation, Coronary Artery Disease
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the…
- Trial name
- NCT00157807
- Testing
- bipolar radiofrequency ablation of persistent and permanent AF
- Where
- 5 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Surgery
Congenital Cardiac Defects
Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery
Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common.
- Trial name
- NCT02686255
- Testing
- complete blood count
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Heart Defect, Congenital, Executive Dysfunction
Executive Function Intervention for Children With Complex Congenital Heart Disease
Children with complex congenital heart disease (cCHD) nowadays survive thanks to medical advances into their teenage years and adulthood. However, many of them have difficulties with so-called executive functions.
- Trial name
- E-Fit Heart (NCT07692958)
- Testing
- E-Fit Intervention
- Where
- Switzerland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Bea Latal
Pulmonary Arterial Hypertension, Eisenmenger Syndrome
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated…
- Trial name
- NCT01397110
- Testing
- respiratory and exercise therapy
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Heidelberg University
Non Syndromic Congenital Heart
Non Syndromic Congenital Heart Defect and Array-CGH in Prenatal Diagnosis
Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations.
- Trial name
- CAPA (NCT02333097)
- Where
- 2 sites in France
- Volunteers
- 78 people
- Sponsor
- Rennes University Hospital