Clinical trials: Septal Defect
Patent Foramen Ovale, Cryptogenic Stroke
Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Embolic Infarction
- Trial name
- LOCATE (NCT07009678)
- Testing
- intravenous access in greater saphenous vein compared to upper extremity site.
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- St. John's Hospital
Patent Foramen Ovale, Cryptogenic Stroke
Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Transient Ischemic Attack Due to Embolism, Atrial Fibrillation
- Trial name
- NCT07724171
- Where
- South Korea
- Volunteers
- 400 people
- Sponsor
- Yonsei University
Heart Septal Defects, Ventricular
Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed.
- Trial name
- pfm-01/2005 (NCT00390702)
- Testing
- transcatheter implantation of a VSD occluder (Nitinol coil)
- Where
- 6 sites in Germany, Israel
- Volunteers
- 103 people
- Sponsor
- pfm medical gmbh
Patent Foramen Ovale
Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
- Trial name
- CAPPRES (NCT05592301)
- Testing
- Diffusion-weighted Magnetic Resonance Imaging (DW-MRI), Transcranial Doppler (TCD), Transthoracic Echocardiogram (TTE)
- Where
- Canada
- Volunteers
- 408 people
- Sponsor
- University Health Network, Toronto
Atrial Septal Defect
Utilization of Confocal Microscopy During Cardiac Surgery
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery.
- Trial name
- NCT03189134
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aditya Kaza
Congenital Heart Disease, Truncus Arteriosus
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new…
- Conditions
- Congenital Heart Disease, Truncus Arteriosus, Pulmonary Atresia, Tetralogy of Fallot
- Trial name
- Right HIIT (NCT06771687)
- Testing
- High intensity interval training
- Where
- 2 sites in Netherlands
- Volunteers
- 38 people
- Sponsor
- Erasmus Medical Center
Heart Valve Disease, Heart Septal Defects, Atrial
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography
The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable alternative for moderate sedation in out-patient diagnostic trans-esophageal echocardiography.
- Trial name
- KDTEE (NCT02867930)
- Testing
- Dexmedetomidine, Ketofol(ketamine+propofol)
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source
PFO Occlusion and Atrial Fibrillation
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials.
- Conditions
- Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source, Patent Foramen Ovale
- Trial name
- NCT04898361
- Testing
- PFO closure
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- University Hospital, Saarland
Thrombosis
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and…
- Trial name
- NCT01086046
- Testing
- Low molecular weight heparin
- Where
- China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Third Military Medical University
Patent Foramen Ovale
Cardiox Shunt Detection Technology Study
The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS).
- Trial name
- NCT01333761
- Testing
- Cardiox FDS
- Where
- 7 sites in United States
- Volunteers
- 71 people
- Sponsor
- Cardiox Corporation
Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery
Prehab2Rehab is a prospective single-arm feasibility study evaluating the implementation of a multimodal, digitally supported prehabilitation program for adults awaiting elective cardiac surgery.
- Conditions
- Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery, Surgical Closure of an Atrial Septal Defect (ASD)
- Trial name
- Prehab2Rehab (NCT07716761)
- Testing
- Digitally supported prehabilitation program
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
Ventricular Septal Defect
Longterm Outcome After Ventricular Septal Defect Closure
Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy…
- Trial name
- NCT02138435
- Testing
- MRI exercise test, Gas-exchange exercise test
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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
Atrial Septal Defect, Successful Device Closure
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape.
- Trial name
- ASD (NCT02097758)
- Testing
- Transcatheter device closure
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
Atrial Septal Defects
Safety and Effectiveness Study of the Solysafe Septal Occluder
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)
- Trial name
- NCT00353509
- Testing
- Device Closure of a Septal Defect
- Where
- Serbia
- Sponsor
- Carag AG
Foramen Ovale, Patent
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable…
- Trial name
- PFOCUS (NCT03232450)
- Testing
- Aspirin, Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder
- Where
- United States
- Sponsor
- Mayo Clinic
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Trial name
- NCT05774288
- Testing
- Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
- Where
- 14 sites in China
- Volunteers
- 244 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Heart Block After Surgery
Rhythm Disturbances After Ventricular Septal Defects
We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta.
- Trial name
- NCT00208624
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Ventricular Septal Defect
Cera™ VSD Occluder Post Market Clinical Follow-up
The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
- Trial name
- NCT05939713
- Testing
- Cera™ VSD occluder implantation
- Where
- 8 sites in Taiwan
- Volunteers
- 152 people
- Sponsor
- Cardiac Children's Foundation Taiwan