Clinical trials: Patent Foramen Ovale, open to volunteers
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
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
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
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
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
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
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
Patent Foramen Ovale (PFO), High Altitude Pulmonary Edema
The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia
Before birth, the foramen ovale is a normal opening in the heart that allows blood to flow from the mother to the baby. After birth, this opening usually closes.
- Trial name
- NCT07742540
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
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
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 (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, 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
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.
Patent Foramen Ovale
CeraFlex PFO Closure System PMCF Study
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
- Trial name
- NCT06120270
- Testing
- CeraFlex PFO Closure System
- Where
- 15 sites in Germany, South Korea
- Volunteers
- 180 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
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, 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
Cryptogenic Ischemic Stroke, Patent Foramen Ovale
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80…
- Trial name
- CLOSE-2 (NCT05387954)
- Testing
- Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting, Antiplatelet therapy
- Where
- 42 sites in France
- Volunteers
- 792 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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