Clinical trials: Atrial Septal Defect
Atrial Septal Defect
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
- Trial name
- NCT05887700
- Testing
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Where
- 10 sites in Brazil, Greece and 1 more
- Volunteers
- 145 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Patent Foramen Ovale, PFO
Emergency/Compassionate Use PFO Occluder
Emergency/compassionate use for the AMPLATZER PFO Occluder
- Trial name
- NCT00584064
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
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
Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy.
- Trial name
- NCT07529028
- Testing
- Absnow II Absorbable Atrial Septal Defect Occluder System, Cera Atrial Septal Defect Occluder
- Volunteers
- 236 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
Patent Foramen Ovale
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or…
- Trial name
- NCT00335296
- Testing
- PFx catheter
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 100 people
- Sponsor
- Cierra
Migraine, Migraine With Aura
PRIMA PFO Migraine Trial
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart…
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Trial name
- PRIMA (NCT00505570)
- Testing
- AMPLATZER® PFO Occluder Device
- Where
- 17 sites in Canada, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders
To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD
- Trial name
- NCT05312554
- Testing
- Iris FIT™ PFO closure system
- Where
- China
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Patent Foramen Ovale, Stroke
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO…
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Trial name
- NCT00201461
- Testing
- STARFlex septal closure system, Best medical therapy
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- NMT Medical
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 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
Varicose Veins
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
- Trial name
- MRI (NCT00442364)
- Testing
- Polidocanol (1%) Microfoam (Varisolve), Endovenous Microfoam Occlusion
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Right to Left Shunt, Patent Foramen Ovale
Right to Left Cardiac Shunt Detection
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal…
- Conditions
- Right to Left Shunt, Patent Foramen Ovale, Atrial Septal Defect
- Trial name
- PFO Detection (NCT01773252)
- Testing
- Flow Detection System
- Where
- 8 sites in United States
- Volunteers
- 141 people
- Sponsor
- Cardiox Corporation
Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO)
FIH Study With CBSO
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
- Trial name
- NCT01960491
- Testing
- Device Closure of Atrial Septal Defect
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Carag AG
Stroke, Patent Foramen Ovale
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO…
- Conditions
- Stroke, Patent Foramen Ovale, PFO
- Trial name
- OCCLUFLEX (NCT05069558)
- Testing
- Investigational PFO Closure Device, Standard of Care PFO Closure Device
- Where
- 48 sites in United States, Canada and 6 more
- Volunteers
- 450 people
- Sponsor
- Occlutech International AB
Foramen Ovale, Patent, Heart Defects, Congenital
InterSEPT: In-Tunnel SeptRx European PFO Trial
The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of…
- Conditions
- Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects
- Trial name
- InterSEPT (NCT01385670)
- Testing
- Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
- Where
- 2 sites in France, Germany
- Volunteers
- 70 people
- Sponsor
- SeptRx, Inc.