Clinical trials: Septal Defect
Nasal Obstruction, Septal Defect
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of…
- Conditions
- Nasal Obstruction, Septal Defect, Allergic Rhinitis, Nasal Polyps
- Trial name
- NCT05287841
- Testing
- Batten batten graft, Septoplasty, Inferior Turbinate Reduction
- Where
- 3 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Migraine Disorders, Heart Septal Defects, Atrial
ESCAPE Migraine Trial
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who…
- Trial name
- NCT00267371
- Testing
- PFO Closure with Premere investigational device., Medical management/current medications per standard of care by personal physician.
- Where
- 37 sites in United States
- Volunteers
- 168 people
- Sponsor
- Abbott Medical Devices
PFO - Patent Foramen Ovale, Migraine
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
- Trial name
- SPRING (NCT04946734)
- Testing
- PFO closure device, Aspirin and clopidogrel, Triptans
- Where
- 21 sites in China
- Volunteers
- 440 people
- Sponsor
- Guangdong Provincial People's Hospital
ASD, Brady Arrythmia
Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
Primary outcomes : Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure Secondary outcomes …
- Trial name
- NCT06761807
- Testing
- Electrophysiology study of heart
- Volunteers
- 65 people
- Sponsor
- Assiut University
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
ASD - Atrial Septal Defect
A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden.
- Trial name
- NCT07273227
- Testing
- Mobile Surgical Vehicle Echocardiography-guided ASD closure Group, Conventional Operating Room Echocardiography-guided ASD closure Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
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
Heart Defects, Congenital, Transposition of Great Vessels
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
- Conditions
- Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular, Endocardial Cushion Defects
- Trial name
- NCT00199771
- Testing
- 7.5% NaCl in 6% dextran 70 solution
- Volunteers
- 14 people
- Sponsor
- Oslo University Hospital
Migraine, Aura
MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant
The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed…
- Conditions
- Migraine, Aura, Patent Foramen Ovale
- Trial name
- NCT00283738
- Testing
- BioSTAR Septal Repair Implant System
- Where
- 2 sites in United States
- Volunteers
- 610 people
- Sponsor
- NMT Medical
Cryptogenic Stroke, Foramen Ovale, Patent
Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.
- Conditions
- Cryptogenic Stroke, Foramen Ovale, Patent, Atrial Fibrillation
- Trial name
- ALFA-ROMEO (NCT04881578)
- Testing
- continuous cardiac monitoring before and after transcatheter PFO closure
- Where
- 6 sites in Switzerland
- Volunteers
- 200 people
- Sponsor
- Raban Jeger
Hypoplastic Left Heart Syndrome, Atrioventricular Canal
Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle
Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS), unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged LV recruitment following bidirectional Glenn…
- Trial name
- NCT03079401
- Testing
- MPC; rexlemestrocel-L
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston Children's Hospital
Patent Foramen Ovale
Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
- Trial name
- NCT01854281
- Where
- Czechia
- Volunteers
- 47 people
- Sponsor
- University Hospital, Motol
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
Atrial Septal Defect
Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect.
- Trial name
- NCT06139679
- Testing
- ASD closure with fenestrated/non-fenestrated patch
- Where
- Indonesia
- Volunteers
- 21 people
- Sponsor
- Dr. Soetomo General Hospital
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Patent Foramen Ovale
Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical…
- Trial name
- NCT00196027
- Testing
- PFX Closure System
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cierra
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
Ventricular Septal Defect
Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital
ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac…
- Trial name
- NCT06492473
- Testing
- ECHO
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Sohag University