Pediatric Lead Extractability and Survival Evaluation (PLEASE)
Ventricular TachycardiaVentricular Fibrillation3 moreThis is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease. ICD lead survival in this patient group is particularly suboptimal, and lead extraction is technically difficult and carries a substantial morbidity risk. Recently, improved ICD lead designs have been released and are currently being utilized in patients. The main aim of the study is to determine if either type of lead performs better in terms of implantation electrical characteristics, long-term survival without breaking, and ease of extractability.
Advanced Reperfusion Strategies for Refractory Cardiac Arrest
Cardiac ArrestExtracorporeal Membrane Oxygenation Complication3 moreThis is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
SD01 Master Study (Safety and Efficacy Study)
Ventricular TachycardiaVentricular Fibrillation1 moreThe study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
SD01 Registry (SD01 ICD Lead)
Ventricular FibrillationVentricular Tachycardia1 moreThis registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
Ventricular FibrillationTachycardia2 moreBIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer. The EuroEco study: Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU. Compares the indicators of patients' safety between the two FU models.
Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and...
Cardiac ArrestSudden Cardiac Death3 moreThe purpose of this research study is to evaluate the effectiveness of metoprolol, a "beta blocker," in treating patients in the hospital with a cardiac arrest. It will be given intravenously (given into a vein). The subjects who will take part in this study are 18 years of age or older, are experiencing a cardiac arrest in the hospital, and are in a life threatening situation. Patients who develop a cardiac arrest require prompt electrical defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In patients who do not respond to electrical defibrillation, current standard of care recommends the use of medications which have been shown to be of unknown benefit. Some people recover from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol will improve survival of patients with a cardiac arrest. A total of 100 patients will be enrolled in the study. Patients will receive either the standard of care with the drug epinephrine or the standard of care plus metoprolol.
ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF...
Cardiac Arrest Due to Underlying Cardiac ConditionVentricular Fibrillation1 moreTo determine if survival to hospital discharge with good neurological outcome for adults ages 18-75 who are resuscitated from out-of-hospital VT/VF cardiac arrest without clinical signs of a heart attack do better by going straight to the cardiac catheterization laboratory or admitted to the intensive care unit for evaluation. The investigators think a large portion of resuscitated patients presenting with VT/VF have ischemic heart disease which is the cause for the arrest. And prompt access to the cardiac catheterization laboratory to reverse the blocked artery will improve survival with good neurological outcomes.
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
Ventricular FibrillationVentricular TachycardiaThe main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
TachycardiaVentricular Fibrillation1 moreThe objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate...
Ventricular TachycardiaVentricular Fibrillation2 moreThe RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death