Trevisio Post-Approval Study
PFO - Patent Foramen OvaleASD - Atrial Septum Defect2 moreA single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices
Improving Care for Children With Congenital Heart Disease.
Heart Disease CongenitalVentricular Septal Defect5 moreEstablish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention selected types of with congenital heart disease.
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain...
Diseases of Mitral ValveAortic Valve Disorder2 moreThe 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)
Feasibility Study on the VERAFEYE System
Atrial Septal DefectAtrial Fibrillation2 moreThe objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
Radiation-Free Heart Catheterization Using MRI
Aortic CoarctationCardiomyopathy4 moreCurrently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
Post Market Registry of the CBSO
Atrial Septal DefectPatent Foramen OvaleMulti centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use
ESCAPE Migraine Trial
Migraine DisordersHeart Septal Defects1 moreThe purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
Philips Intracardiac Echocardiography (ICE) Clinical Registry
Atrial FibrillationStroke7 moreThe purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
Lifetech CeraFlex™ Post-Market Surveillance Study
Patent Foramen OvaleAtrial Septal Defect1 moreThe purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).
FIH Study With CBSO
Atrial Septal Defect (ASD)Patent Foramen Ovale (PFO)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).