Clinical trials: Foramen Ovale, Patent
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
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
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.
Patent Foramen Ovale, Stroke
PFO ACCESS Registry
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.
- Trial name
- NCT00583401
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Hummingbird ICE Study
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of…
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT07552272
- Testing
- ICE Image Guidance
- Volunteers
- 1,000 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Stroke, PFO - Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a…
- Trial name
- REDUCE PAS (NCT03821129)
- Testing
- PFO closure with GORE® CARDIOFORM Septal Occluder
- Where
- 45 sites in United States
- Volunteers
- 636 people
- Sponsor
- W.L.Gore & Associates
Foramen Ovale, Patent, Heart Catheterization
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding…
- Conditions
- Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
- Trial name
- 09k003 (NCT00968032)
- Testing
- Nit-Occlud® PFO
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- pfm medical gmbh
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
PFO, PFO - Patent Foramen Ovale
Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS 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 OUS (NCT07698951)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- Serbia
- Volunteers
- 15 people
- Sponsor
- Recross Cardio, Inc.
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
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
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
Heart Septal Defect, Heart Septal Defects, Atrial
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
- Conditions
- Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities
- Trial name
- ASCENT ASD (NCT04591392)
- Testing
- reSept ASD Occluder
- Where
- 32 sites in United States, Canada and 2 more
- Volunteers
- 250 people
- Sponsor
- atHeart Medical
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale, Cryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
- Trial name
- NCT05537753
- Testing
- Encore PFO closure device, FDA-approved PFO closure device
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Encore Medical Inc.
Patent Foramen Ovale, Stroke
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO…
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Trial name
- NCT00201461
- Testing
- STARFlex septal closure system, Best medical therapy
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- NMT Medical
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Trial name
- NCT05774288
- Testing
- Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
- Where
- 14 sites in China
- Volunteers
- 244 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
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
Patent Foramen Ovale
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or…
- Trial name
- NCT00335296
- Testing
- PFx catheter
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 100 people
- Sponsor
- Cierra