Clinical trials: PFO
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, 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
Patients With Migraine and PFO
The Coherex FlatStent™ EF PFO Migraine Registry
A prospective, single arm, multicenter clinical registry evaluating the change in migraine headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with the Coherex FlatStent™ EF PFO Closure System.
- Trial name
- NCT01280578
- Testing
- Transcatheter PFO Closure
- Volunteers
- 3 people
- Sponsor
- Coherex Medical
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
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
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
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
Migraine
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9…
- Trial name
- NCT00369499
- Testing
- PFO Closure
- Where
- Germany
- Volunteers
- 656 people
- Sponsor
- Abbott Medical Devices
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
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, Migraine With Aura
PRIMA PFO Migraine Trial
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart…
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Trial name
- PRIMA (NCT00505570)
- Testing
- AMPLATZER® PFO Occluder Device
- Where
- 17 sites in Canada, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale (PFO)
Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale.
- Trial name
- NCT07726927
- Testing
- Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
- Volunteers
- 244 people
- Sponsor
- Shenzhen Bihe Medical Co., Ltd
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 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
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
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
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.
Non-Small Cell Lung Cancer Stage IV
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with…
- Trial name
- NCT02450539
- Testing
- Abemaciclib, Docetaxel
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 159 people
- Sponsor
- Eli Lilly and Company
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
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