Clinical trials: Heart Septal Defects
Embolic Stroke of Undetermined Source, Transient Ischemic Attack
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD…
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Trial name
- BUBL (NCT04604015)
- Testing
- NeuralBot Investigational System, Transthoracic Echocardiography (TTE)
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
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.
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
Patent Foramen Ovale, PFO
The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical…
- Conditions
- Patent Foramen Ovale, PFO, Stroke, TIA
- Trial name
- CryptoCard (NCT01018355)
- Testing
- Percutaneous device closure of patent foramen ovale
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Hillerod Hospital, Denmark
Atrial Septal Defect
The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics
Patients received a MitraClip procedure because of a leakiness of their mitral valves. During this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness.
- Trial name
- MitraClipASD (NCT02453451)
- Testing
- 2D-/3D-TTE, 3D-TEE, Walking Test
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- RWTH Aachen University
Foramen Ovale, Patent, Septal Defect, Atrial
Stitch Closure of PFO and Septal Repair
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal…
- Conditions
- Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
- Trial name
- STITCH (NCT03373929)
- Testing
- PFO Closure Rate, Published PFO Device Closure
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- HeartStitch.Com
Stroke, Patent Foramen Ovale
AMPLATZER PFO Occluder Post Approval Study
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
- Trial name
- PFO PAS (NCT03309332)
- Testing
- AMPLATZER™ PFO Occluder
- Where
- 88 sites in United States, Canada and 5 more
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
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
Muscular Ventricular Septal Defect
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- Trial name
- mVSD Registry (NCT05329350)
- Testing
- Occlutech muscular ventricular septal defect (mVSD) Occluder
- Where
- 6 sites in Ireland, Turkey (Türkiye) and 1 more
- Volunteers
- 50 people
- Sponsor
- Occlutech International AB
Pulmonary Embolism (PE), Right-to-Left Shunt
Pulmonary Embolism and Right-to-Left Shunts
Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people.
- Conditions
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke, Atrial Septal Defects
- Trial name
- PEaRLS (NCT07519876)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Tufts Medical Center
Ventricular Septal Defect
Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children
The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD).
- Trial name
- NCT06214182
- Where
- China
- Volunteers
- 3 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
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
VSD, Pediatric Cardiology
Follow-up After Percutaneous Device Closure of Ventricular Septal Defects
Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies.
- Trial name
- NCT07715032
- Testing
- • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder
- Volunteers
- 85 people
- Sponsor
- Assiut University
Patent Foramen Ovale, Atrial Septal Defect
Lifetech CeraFlex™ Post-Market Surveillance Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™…
- Conditions
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT02621528
- Testing
- CeraFlex
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Atrial Septal Defect, Pulmonary Hypertension
Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension
The purpose of the study is to compare exercise capacity, cardiac contractility, pulmonary vascular pressures and heart rate variability between patients with an atrial septal defect and healthy controls.
- Trial name
- NCT03565471
- Testing
- Echocardiography, Right side catheterization, Exercise test
- Where
- Denmark
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Atrial Septal Defect
Utilization of Confocal Microscopy During Cardiac Surgery
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery.
- Trial name
- NCT03189134
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aditya Kaza
Hypoplastic Left Heart Syndrome, Aortic Coarctation
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
- Conditions
- Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
- Trial name
- NCT03147014
- Testing
- Maternal hyperoxygenation
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Beijing Anzhen Hospital
Heart Septal Defects, Ventricular, Aortic Valve Insufficiency
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age.
- Trial name
- NCT00173186
- Where
- Taiwan
- Volunteers
- 411 people
- Sponsor
- National Taiwan University Hospital
Patent Foramen Ovale
Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches
The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at embryonic stage, is closed normally at 5-7 months after birth.
- Trial name
- NCT02777359
- Testing
- the transcatheter closure of PFO
- Where
- China
- Volunteers
- 100 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University