Clinical trials: Heart Septal Defects, Atrial
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
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
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
Migraine, Patent Foramen Ovale
Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing…
- Trial name
- NCT06953622
- Testing
- Conservative treatment, Antipaletet drug, Patent Foramen Ovale Closure
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Peking University Third Hospital
Patent Foramen Ovale, Cryptogenic Stroke
Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Transient Ischemic Attack Due to Embolism, Atrial Fibrillation
- Trial name
- NCT07724171
- Where
- South Korea
- Volunteers
- 400 people
- Sponsor
- Yonsei University
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
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale
Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler
Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.
- Trial name
- NCT02383836
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Hillel Yaffe Medical Center
Foramen Ovale, Patent, Stroke, Ischemic
NobleStitch EL STITCH Trial is a PFO Comparative Trial
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
- Trial name
- STITCH (NCT04339699)
- Testing
- NobleStitch™EL Suture Mediated Closure System, Amplatzer PFO Occluder
- Where
- 2 sites in United States, Italy
- Volunteers
- 640 people
- Sponsor
- Nobles Medical Technologies II Inc
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
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
Congenital Heart Disease, Thiamine Deficiency
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of…
- Conditions
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect
- Trial name
- NCT06298344
- Testing
- Thiamine
- Where
- Indonesia
- Volunteers
- 86 people
- Sponsor
- Universitas Sumatera Utara
Atrial Septal Defect
The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion.
- Trial name
- NCT05371366
- Testing
- ASD closure with the novel occluder (ReAces), ASD closure with normal occluder
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Shanghai Zhongshan Hospital
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
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
PFO, PFO - Patent Foramen Ovale
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a…
- Conditions
- PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale
- Trial name
- PROTEA-PFO (NCT07172464)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Recross Cardio, Inc.
General Anesthesia, Dexmedetomidine
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous…
- Conditions
- General Anesthesia, Dexmedetomidine, Ketamine, Local Infiltration
- Trial name
- NCT06431178
- Testing
- General Anesthesia, Local anesthesia
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
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
Patent Foramen Ovale, Cryptogenic Stroke
Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Embolic Infarction
- Trial name
- LOCATE (NCT07009678)
- Testing
- intravenous access in greater saphenous vein compared to upper extremity site.
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- St. John's Hospital
Heart Defects,Congenital, Heart Septal Defects, Atrial
Fluid Balance During Closure of Atrial Septal Defect
This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and…
- Trial name
- NCT01757743
- Where
- Norway
- Volunteers
- 41 people
- Sponsor
- Oslo University Hospital