Clinical trials: Cardiac Defect
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Atrial Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
Anemia
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low.
- Trial name
- NCT00459225
- Testing
- Iron (ferrous sulfate)
- Where
- United States
- Sponsor
- Emory University
Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
The purpose of this study is to investigate the security and validity of transesophageal echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in treatment of infundibular ventricular septal…
- Conditions
- Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD, Double Outlet Right Ventricle, Subaortic VSD, Double Outlet Right Ventricle, Subpulmonary VSD
- Trial name
- NCT02361008
- Testing
- TEE-guided perventricular device closure without CBP, Surgery repair with CBP
- Where
- China
- Volunteers
- 20,121,212 people
- Sponsor
- Bentong Yu
Congenital Disorders
Pulmonary Hypertension in Trisomy 21 Patients
Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect.
- Trial name
- NCT00478296
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Healthcare of Atlanta
Atrial Septal Defect, Patent Foramen Ovale
Canadian Adult Congenital Heart Disease Intervention Registry
The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of…
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale, Tetralogy of Fallot, Fontan
- Trial name
- C-ACHDiR (NCT04288596)
- Testing
- Participants undergoing ACHD intervention
- Where
- Canada
- Volunteers
- 9,000 people
- Sponsor
- University Health Network, Toronto
Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery
Prehab2Rehab is a prospective single-arm feasibility study evaluating the implementation of a multimodal, digitally supported prehabilitation program for adults awaiting elective cardiac surgery.
- Conditions
- Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery, Surgical Closure of an Atrial Septal Defect (ASD)
- Trial name
- Prehab2Rehab (NCT07716761)
- Testing
- Digitally supported prehabilitation program
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
Ventricular Septal Defect
Longterm Outcome After Ventricular Septal Defect Closure
Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy…
- Trial name
- NCT02138435
- Testing
- MRI exercise test, Gas-exchange exercise test
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
This prospective observational cohort study evaluates a precision neuromuscular management strategy in pediatric patients undergoing minimally invasive cardiac surgery (MICS).
- Conditions
- Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery, Early Extubation Pathway, TOF-Guided Sugammadex Administration
- Trial name
- TOF (NCT07798011)
- Testing
- Sugammadex
- Where
- Vietnam
- Volunteers
- 80 people
- Sponsor
- Dr. Nguyen Thi Thu Hang
Conduction Defect
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV…
- Trial name
- STEP IV (NCT05457673)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Atrial Septal Defect, Ventricular Septal Defect
Regional Anesthesia Following Pediatric Cardiac Surgery
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural
- Trial name
- NCT05688670
- Testing
- Regional Anesthesia, Wound infiltration, Ropivacaine 0.2% Injectable Solution
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Duke University
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
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal…
- Trial name
- NCT07431437
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
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.
Congenital Heart Disease
Exercise Training in Children With Congenital Heart Defect
The purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital…
- Trial name
- NCT00930800
- Testing
- Exercise
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Conduction Defect
AtaCor Subcostal Temporary Extravascular Pacing III Study
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.
- Trial name
- STEP III (NCT04538287)
- Testing
- AtaCor StealthTrac Lead
- Where
- 4 sites in Czechia, New Zealand and 1 more
- Volunteers
- 33 people
- Sponsor
- AtaCor Medical, Inc.
Atrial Septal Defect
A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children
This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children.
- Trial name
- NCT02276599
- Testing
- Volume expansion
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Brian Schloss
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
Ventricular Septal Defect
Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?
The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery.
- Trial name
- NCT07393243
- Testing
- Clear priming of the bypass pump
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Seattle Children's Hospital