Clinical trials: Atrial Septal Defects, open to volunteers
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.
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.
Patent Foramen Ovale
Russian Registry of Endovascular Closure of PFO
The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided…
- Trial name
- ENDOVAL (NCT06156670)
- Testing
- PFO closure
- Where
- Russia
- Volunteers
- 700 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
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
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.
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
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
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
Atrial Septal Defect (ASD)
A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment.
- Trial name
- PANNA-ASD (NCT07054541)
- Testing
- Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention
- Where
- China
- Volunteers
- 666 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
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
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
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.
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Migraine Disorders, Patent Foramen Ovale
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura.
- Conditions
- Migraine Disorders, Patent Foramen Ovale, Right-to-Left Shunt, Cardiac
- Trial name
- NCT07170176
- Testing
- Percutaneous Patent Foramen Ovale Closure, No Intervention
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
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
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
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
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