Clinical trials: Patent Foramen Ovale
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
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
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 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
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
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
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Varicose Veins
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
- Trial name
- MRI (NCT00442364)
- Testing
- Polidocanol (1%) Microfoam (Varisolve), Endovenous Microfoam Occlusion
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation