Clinical trials: Foramen Ovale, Patent
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
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 Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
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, Patent Foramen Ovale
Patent Foramen Ovale Closure in Migraine
The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are: Whether PFO closure is more effective in the treatment of migraine…
- Trial name
- NCT06192173
- Testing
- Percutaneous PFO closure
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Haiyan Wang
Ischemic Brain Injury, Stroke
Clinical Proteomic Research for the Brain
The study of plasma and urine proteomic profiles in patients with ischemic brain injury is important to better understanding of the mechanisms by which thrombolytic agents or other therapy affects clinical outcomes.
- Conditions
- Ischemic Brain Injury, Stroke, Healthy Individual, Patent Foramen Ovale (PFO)
- Trial name
- "CPR Brain" (NCT00983723)
- Where
- United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Patent Foramen Ovale, PFO
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
- Trial name
- NCT05893758
- Testing
- The Cera™ PFO Occluder
- Where
- 5 sites in Poland
- Volunteers
- 94 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect Secundum
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
- Trial name
- ASO 522 (NCT02353351)
- Testing
- atrial septal occluder
- Where
- 65 sites in United States
- Volunteers
- 602 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
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
ASD2(Secundum Atrial Septal Defect)
Outcomes of Transcatheter ASD Closure Guided by 3D-TEE
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance…
- Trial name
- NCT03867708
- Testing
- ASD device closure
- Sponsor
- Assiut University
Closure of the Foramen Ovale and Ductus Arteriosus
Timing of Closure of Patent Foramen Ovale Following Birth
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent…
- Trial name
- NCT01032785
- Testing
- no interventions
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
PFO - Patent Foramen Ovale, Migraine
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
- Trial name
- SPRING (NCT04946734)
- Testing
- PFO closure device, Aspirin and clopidogrel, Triptans
- Where
- 21 sites in China
- Volunteers
- 440 people
- Sponsor
- Guangdong Provincial People's Hospital
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
Patent Foramen Ovale, Decompression Illness
Patent Foramen Ovale Closure Reduce in SCUBA-divers
It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).
- Trial name
- NCT03997084
- Testing
- phone interviews
- Volunteers
- 9 people
- Sponsor
- Skane University Hospital
Atrial Septal Defect (ASD)
Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure.
- Trial name
- NCT06655935
- Testing
- Ordinary Transcatheter ASD closure, modified transcatheter ASD closure
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Egyptian Biomedical Research Network
Patent Foramen Ovale
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.
- Trial name
- PFO (NCT02882815)
- Testing
- IrisFIT PFO Occluder
- Where
- 3 sites in Germany, Ireland
- Volunteers
- 85 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Migraine Headaches
Patent Foramen Ovale in Children With Migraine Headaches
This study will be the first to provide data about the relationship between PFO and migraine in children. By establishing the actual prevalence, we will better understand if PFO plays a role in the occurence of pediatric migraine…
- Trial name
- NCT00750594
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- University of Utah
Patent Foramen Ovale
Long-term Procedural and Device Related Complications of PFO Closure
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
- Trial name
- NCT06413147
- Testing
- PFO closure
- Volunteers
- 100 people
- Sponsor
- Xuanwu Hospital, Beijing