The purpose of this research study is to evaluate the different ways to program a Cardiac Resynchronization Therapy Defibrillator (CRT-D) through the use of software built into the CRT-D system. A CRT-D does not cure heart failure, but many people who receive a CRT device notice that they feel better. The objective of the device programming required by the SMART CRT study is to provide heart failure therapy which improves heart function.
The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the Amulet device is safe and effective when compared to another LAA closure device made by another medical device company named Boston Scientific. The other device, called the WATCHMAN LAA closure device, is approved for use in the United States and many countries in Europe, Australia, and other nations. It is implanted in some patients with non-valvular atrial fibrillation to reduce the risk of stroke. The WATCHMAN device will be used as the Control device in this study.
The primary objective is to assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bpm. The UNTOUCHED study will test this programming scheme designed to minimize inappropriate and unnecessary shocks in patients who have an indication for primary prevention of sudden cardiac death and low ejection fraction. Subjects will be followed semi-annually according to standard of care for a minimum of 18 months post implant.