Clinical trials: Septal Defect, open to volunteers
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
Congenital Heart Defects, VSD
Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve…
- Trial name
- ABSORB-VSD (NCT07040579)
- Testing
- transcatheter closure of outlet VSDs with bioabsorbable occluders
- Where
- China
- Volunteers
- 50 people
- Sponsor
- First Affiliated Hospital of Guangxi Medical University
Atrial Septal Defect
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
The objective of this post-market study is to: collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder identify previously unknown side-effects
- Trial name
- NCT06849635
- Where
- 6 sites in Poland
- Volunteers
- 139 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Sinus Venosus Defect, Congenital Heart Disease
OPTImal Treatment of Sinus VENOSUS Defect
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect.
- Conditions
- Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
- Trial name
- OPTIVENOSUS (NCT05865119)
- Testing
- OPTIMUS covered stent, Surgical correction of a SVD
- Where
- 13 sites in France
- Volunteers
- 60 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
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, Cryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
- Trial name
- NCT05537753
- Testing
- Encore PFO closure device, FDA-approved PFO closure device
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Encore Medical Inc.
Thrombosis Cardiac, Atrial Septal Defect
Cerebral Microembolization Associated With PFO Closure
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ…
- Conditions
- Thrombosis Cardiac, Atrial Septal Defect, Patent Foramen Ovale (PFO)
- Trial name
- NCT06347276
- Testing
- PFO occluder; ASD occluder
- Where
- China
- Volunteers
- 800 people
- Sponsor
- China National Center for Cardiovascular Diseases
Atrial Fibrillation, Atrial Flutter
Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure
"The primary objective of the study is to evaluate whether the incidence of symptomatic or asymptomatic atrial fibrillation, atrial flutter, and atrial tachycardia within 30 days after percutaneous closure of idiopathic patent…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Heart Septal Defects, Atrial
- Trial name
- BRAVE PFO (NCT07123506)
- Testing
- Beta-blocker treatment group, Non-treatment group
- Where
- South Korea
- Volunteers
- 350 people
- Sponsor
- Yonsei University
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
Ventricular Septal Defect, Papillary Muscle Rupture
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on…
- Conditions
- Ventricular Septal Defect, Papillary Muscle Rupture, Cardiac Rupture, Pseudoaneurysm
- Trial name
- CAUTION 2 (NCT06676345)
- Testing
- Surgical treatment, Percutaneous treatment
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Maastricht University Medical Center
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
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
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
Congenital Heart Disease, Coarctation of Aorta
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative…
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia
- Trial name
- NCT06768008
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Beijing Anzhen Hospital
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
Cardiovascular Diseases, Cardiovascular Abnormality
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormality, Heart Defects, Congenital, Heart Septal Defects
- Trial name
- BIOCLOSE-PFO (NCT07300358)
- Testing
- Active Comparator, Experimental
- Volunteers
- 258 people
- Sponsor
- Shanghai Lingsi Medical Technology Co., Ltd.
Patent Oval Foramen
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter.
- Trial name
- NCT06793969
- Testing
- Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage, Conventional technique to pass the PFO tunnel
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RenJi Hospital
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- Trial name
- NCT07425171
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
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