Clinical trials: Foramen Ovale, Patent, open to volunteers
Atrial Septal Defect, Patent Foramen Ovale
Canadian Adult Congenital Heart Disease Intervention Registry
The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of…
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale, Tetralogy of Fallot, Fontan
- Trial name
- C-ACHDiR (NCT04288596)
- Testing
- Participants undergoing ACHD intervention
- Where
- Canada
- Volunteers
- 9,000 people
- Sponsor
- University Health Network, Toronto
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
Migraine Disease, Patent Foramen Ovale
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO).
- Trial name
- COMFORT-PFO (NCT07629635)
- Testing
- Prasugrel 5mg, Transcatheter Closure of Patent Foramen Ovale
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease.
- Trial name
- ASSEE-SHD (NCT07848152)
- Where
- 11 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Hereditary Haemorrhagic Telangiectasia, PFO - Patent Foramen Ovale
Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device
The goal of this clinical trial is to learn how well the SONAS ultrasound device can detect right-to-left shunts of adults with hereditary hemorrhagic telangiectasia (HHT) who are already scheduled for a contrast bubble…
- Conditions
- Hereditary Haemorrhagic Telangiectasia, PFO - Patent Foramen Ovale, Pulmonary Arteriovenous Malformation
- Trial name
- SONAS (NCT07414446)
- Testing
- Transcranial Ultrasound Device
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- St. Antonius Hospital
Ischemic Stroke, Patent Foramen Ovale
Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.
- Trial name
- PACIFIC-PFO (NCT06983795)
- Testing
- PFO closure using approved PFO closure devices, Surgical PFO closure, Medical management
- Where
- Singapore
- Volunteers
- 1,000 people
- Sponsor
- National University Hospital, Singapore
Epilepsy (treatment Refractory)
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population.
- Trial name
- PREDICT-PFO (NCT06863350)
- Testing
- patent foramen ovale closure
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sichuan University
Stroke
Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial…
- Trial name
- NCT06670781
- Testing
- Experimental: Intervention arm: Goal-Directed Valsalva maneuver, Control - standard of care: Self-Directed Valsalva maneuver
- Where
- 2 sites in Canada
- Volunteers
- 488 people
- Sponsor
- Ottawa Heart Institute Research Corporation
PFO - Patent Foramen Ovale, Migraine
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults.
- Conditions
- PFO - Patent Foramen Ovale, Migraine, Migraine Headache, Migraine Headache, With or Without Aura
- Trial name
- BioMetal (NCT06203873)
- Testing
- Biodegradable occluder, Metal occluder
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Embolic Stroke of Undetermined Source
Prospective Registry of Elderly ESUS With PFO
Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS).
- Trial name
- COACH_ESUS (NCT05238610)
- Testing
- PFO closure
- Where
- South Korea
- Volunteers
- 1,200 people
- Sponsor
- Asan Medical Center
Ischemic Stroke, Embolic Stroke of Undetermined Source
SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort…
- Conditions
- Ischemic Stroke, Embolic Stroke of Undetermined Source, Patent Foramen Ovale (PFO), Elderly
- Trial name
- SENIOR (NCT07479147)
- Testing
- PFO closure, Medication
- Where
- 3 sites in Taiwan
- Volunteers
- 400 people
- Sponsor
- Taichung Veterans General Hospital
Pulmonary Embolism (PE), Right-to-Left Shunt
Pulmonary Embolism and Right-to-Left Shunts
Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people.
- Conditions
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke, Atrial Septal Defects
- Trial name
- PEaRLS (NCT07519876)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Tufts Medical Center
Patent Foramen Ovale, Cryptogenic Stroke
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment
- Trial name
- STOP (NCT05907694)
- Testing
- Transcatheter PFO closure, Optimal medical treatment
- Where
- 2 sites in Canada
- Volunteers
- 714 people
- Sponsor
- Josep Rodes-Cabau
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
Patent Foramen Ovale, Ischemic Stroke
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- Trial name
- HALTI (NCT04475510)
- Testing
- Antiplatelet treatment discontinuation
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Josep Rodes-Cabau
Atrial Septal Defect, Patent Foramen Ovale
AWARE Registry: Wearable ECG in Structural Heart Interventions
This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type…
- Trial name
- NCT06236776
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Yonsei University
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
Stroke, PFO - Patent Foramen Ovale
WSO BEAT STROKE Initiative
The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice…
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Atrial Fibrillation (AF)
- Trial name
- BEAT STROKE (NCT06606054)
- Testing
- Educational and implementation Neurocardiology tool, No educational or implementation tool will be provided
- Where
- Canada
- Volunteers
- 2,400 people
- Sponsor
- Luciano A. Sposato
Patent Foramen Ovale
Internal Microstructure of Patent Foramen Ovale Related to Stroke
This study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these…
- Trial name
- IMPORT (NCT04686253)
- Testing
- not appliable
- Where
- 2 sites in China
- Volunteers
- 1,200 people
- Sponsor
- China National Center for Cardiovascular Diseases
ASD2(Secundum Atrial Septal Defect)
Dapagliflozin and Right Heart Recovery After ASD Device Closure
The aim of this study is to evaluate the clinical and echocardiographic influence of dapagliflozin on right ventricular reverse remodeling in adult patients following successful transcatheter Atrial Septal Defect (ASD) device…
- Trial name
- NCT07823972
- Testing
- trans catheter device closure
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Assiut University