Clinical trials: Septal Defect
Stroke, Patent Foramen Ovale
AMPLATZER PFO Occluder Post Approval Study
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
- Trial name
- PFO PAS (NCT03309332)
- Testing
- AMPLATZER™ PFO Occluder
- Where
- 88 sites in United States, Canada and 5 more
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
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.
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
Congenital Disorders
Pulmonary Hypertension in Trisomy 21 Patients
Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect.
- Trial name
- NCT00478296
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Healthcare of Atlanta
Ischemic Stroke, Patent Foramen Ovale
Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke than in control subjects. Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral anticoagulants, and…
- Conditions
- Ischemic Stroke, Patent Foramen Ovale, Atrial Septal Aneurysm, Migraine
- Trial name
- CLOSE (NCT00562289)
- Testing
- aspirin, Antivitamins K or rivaroxaban or dabigatran or apixaban, Devices for PFO closure
- Where
- France
- Volunteers
- 664 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Diseases of Mitral Valve, Aortic Valve Disorder
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
- Conditions
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
- Trial name
- NCT01536717
- Testing
- Articaine hydrochloride 2% solution, Sodium Chloride
- Where
- 2 sites in Finland
- Volunteers
- 36 people
- Sponsor
- Helsinki University Central Hospital
Obstructive Sleep Apnea, Patent Foramen Ovale
Close Obstructive Sleep Apnea (OSA) Trial
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
- Trial name
- NCT06113562
- Testing
- PFO closure
- Sponsor
- University of Miami
Stroke, Cardiac Disease
Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease
Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our…
- Trial name
- NCT04352790
- Volunteers
- 878 people
- Sponsor
- University Hospital Tuebingen
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
Ventricular Septal Defect, Pulmonary Hypertension
The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief…
- Trial name
- NCT01313832
- Testing
- remote ischemic preconditioning (RIPC)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital
Foramen Ovale Patent
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles)…
- Trial name
- NCT02351076
- Where
- Czechia
- Volunteers
- 44 people
- Sponsor
- University Hospital Ostrava
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
Ventricular Septal Defect
The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.
The overall objective for this study is to test whether β2-agonists will affect the cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.
- Trial name
- NCT02914652
- Testing
- Salbutamol
- Where
- Denmark
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
General Anesthesia, Dexmedetomidine
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous…
- Conditions
- General Anesthesia, Dexmedetomidine, Ketamine, Local Infiltration
- Trial name
- NCT06431178
- Testing
- General Anesthesia, Local anesthesia
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
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
Ventricular Septal Defects
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER…
- Trial name
- VPA (NCT00647387)
- Testing
- Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
- Where
- 51 sites in United States, Canada
- Volunteers
- 92 people
- Sponsor
- Abbott Medical Devices
Stroke, Foramen Ovale, Patent
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism.
- Trial name
- PFO-HUG (NCT01149447)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- University Hospital, Geneva
Brain Infarction, Ischemic Stroke
Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and…
- Conditions
- Brain Infarction, Ischemic Stroke, Thrombosis, Foramen Ovale, Patent
- Trial name
- SECRETO (NCT01934725)
- Where
- 19 sites in Estonia, Finland and 11 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- SECRETO Study Consortium
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