Clinical trials: Septal Defect
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
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- Trial name
- NCT07425171
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO)
FIH Study With CBSO
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
- Trial name
- NCT01960491
- Testing
- Device Closure of Atrial Septal Defect
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Carag AG
Secundum Atrial Septal Defects
Occlutech Septal Occluder (Figulla Flex II) Study
The objectives of the study are: To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects To determine the safety of the…
- Trial name
- NCT04488120
- Testing
- transcatheter closure of secundum atrial septal defects in patients
- Volunteers
- 175 people
- Sponsor
- Occlutech International AB
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
Migraine Headaches, Patent Foramen Ovale
PREMIUM Migraine Trial
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
- Trial name
- NCT00355056
- Testing
- AMPLATZER PFO Occluder
- Where
- 30 sites in United States
- Volunteers
- 230 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
- Trial name
- NCT05360771
- Testing
- SnowyTM PFO closure system, Cardi-o-fix PFO occluder
- Where
- China
- Volunteers
- 242 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Membranous Ventricular Septal Defects
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.
- Trial name
- NCT00578708
- Testing
- AMPLATZER Membranous VSD Occluder
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Atrial Septal Defect, Patent Foramen Ovale
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).
- Trial name
- NCT00207376
- Testing
- Solysafe Septal Occluder
- Where
- Germany
- Sponsor
- Carag AG
Foramen Ovale, Patent
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke)…
- Trial name
- NCT00196040
- Testing
- PFX Closure System
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cierra
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.
Patent Foramen Ovale, PFO
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
- Trial name
- NCT05893758
- Testing
- The Cera™ PFO Occluder
- Where
- 5 sites in Poland
- Volunteers
- 94 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
- Trial name
- ASSURED (NCT02985684)
- Testing
- GORE® CARDIOFORM ASD Occluder
- Where
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
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
Patent Foramen Ovale, PFO
Emergency/Compassionate Use PFO Occluder
Emergency/compassionate use for the AMPLATZER PFO Occluder
- Trial name
- NCT00584064
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
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
Migraine, Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
- Conditions
- Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
- Trial name
- RELIEF (NCT04100135)
- Testing
- Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel)
- Where
- 15 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
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
Patent Foramen Ovale, Stroke
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder…
- Conditions
- Patent Foramen Ovale, Stroke, Transient Ischemic Attack (TIA)
- Trial name
- SAFE-PFO (NCT07380490)
- Testing
- PFO Closure procedure
- Where
- Germany
- Volunteers
- 1,260 people
- Sponsor
- Giuseppe Tarantini
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.