Clinical trials: Septal Defect
Perimembranous Ventricular Septal Defect
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
- Trial name
- NCT04034498
- Where
- 8 sites in Ireland, Thailand and 2 more
- Volunteers
- 50 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.
Atrial Septal Defect, Pulmonary Hypertension
Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension
The purpose of the study is to compare exercise capacity, cardiac contractility, pulmonary vascular pressures and heart rate variability between patients with an atrial septal defect and healthy controls.
- Trial name
- NCT03565471
- Testing
- Echocardiography, Right side catheterization, Exercise test
- Where
- Denmark
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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.
Atrial Septal Defect
The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion.
- Trial name
- NCT05371366
- Testing
- ASD closure with the novel occluder (ReAces), ASD closure with normal occluder
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Shanghai Zhongshan Hospital
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Hummingbird ICE Study
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of…
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT07552272
- Testing
- ICE Image Guidance
- Volunteers
- 1,000 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Stroke, PFO - Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a…
- Trial name
- REDUCE PAS (NCT03821129)
- Testing
- PFO closure with GORE® CARDIOFORM Septal Occluder
- Where
- 45 sites in United States
- Volunteers
- 636 people
- Sponsor
- W.L.Gore & Associates
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
PFO - Patent Foramen Ovale, Migraine
COMPETE Cohort Study
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO).
- Trial name
- NCT06033937
- Testing
- PFO occlusion
- Where
- China
- Volunteers
- 242 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Congenital Heart Disease, Cardiopulmonary Bypass
Acetaminophen for Oxidative Stress After Cardiopulmonary Bypass
The current proposal tests the central hypothesis that acetaminophen will attenuate the oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in children undergoing cardiac surgery.
- Trial name
- NCT01228305
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt University Medical Center
Stroke, Patent Foramen Ovale
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of…
- Conditions
- Stroke, Patent Foramen Ovale, Atrial Fibrillation, Atrial Flutter
- Trial name
- IMPROVE (NCT04738071)
- Testing
- PFO closure
- Where
- Canada
- Volunteers
- 3,730 people
- Sponsor
- Luciano A. Sposato
Foramen Ovale, Patent
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?
- Trial name
- EPIC-FOPCohort (NCT04987008)
- Where
- 3 sites in France
- Volunteers
- 53 people
- Sponsor
- University Hospital, Brest
Perimembranous Ventricular Septal Defect
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult…
- Trial name
- PERI-CLOSE (NCT06823635)
- Testing
- Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
- Where
- 25 sites in Denmark, Egypt and 15 more
- Volunteers
- 2,000 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Migraine With Aura
Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
The PFOCUS Study aims to clarify the relationship between patent foramen ovale (PFO) and migraine with aura (MA). Patients diagnosed with MA according to ICHD-3 criteria will be classified as cases (PFO+) or controls (PFO-) based…
- Trial name
- PFOCUS (NCT07349004)
- Testing
- Intervention
- Where
- Italy
- Volunteers
- 240 people
- Sponsor
- Azienda Usl di Bologna
Platelet Aggregation, Spontaneous, Migraine With Aura
pLatelEts And MigRaine iN patEnt foRamen Ovale
Migraine is a common, chronic neurovascular disorder characterized by attacks of severe headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling neurological symptoms.
- Conditions
- Platelet Aggregation, Spontaneous, Migraine With Aura, Patent Foramen Ovale
- Trial name
- LEARNER (NCT03521193)
- Testing
- patent foramen ovale closure
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Centro Cardiologico Monzino
Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients
The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified…
- Trial name
- NCT02861963
- Testing
- Experimental: RVOT reconstruction by femoral allogenic vein valve conduit, Systemic-to-pulmonary artery shunts
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Stroke, PFO - Patent Foramen Ovale
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
- Trial name
- PROOF (NCT04029233)
- Testing
- Occlutech PFO Occluder
- Where
- 17 sites in Canada, France and 2 more
- Volunteers
- 582 people
- Sponsor
- Occlutech International AB
Embolic Stroke of Undetermined Source, Transient Ischemic Attack
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD…
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Trial name
- BUBL (NCT04604015)
- Testing
- NeuralBot Investigational System, Transthoracic Echocardiography (TTE)
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Atrial Septal Defects, Ventricular Septal Defects
Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions
Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.
- Trial name
- NCT02552485
- Testing
- No intervention was applied, because it is an observational study
- Where
- Belgium
- Volunteers
- 93 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Patent Foramen Ovale
Does Patent Foramen Ovale Size Matter in Men and Women
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial.
- Trial name
- NCT03904277
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Oregon