The purpose of this clinical study is to see whether a medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm.The DiamondTemp Ablation System being evaluated in this research study is investigational because it is not approved by the FDA for the treatment of atrial fibrillation by radiofrequency ablation. The DiamondTemp System is like systems currently being used to treat atrial fibrillation with radiofrequency ablation including the control system that participants could be randomized to.
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.
This study is being done to see if receiving electrical treatment from a cardiac resynchronization therapy (CRT) device with the AdaptivCRT (aCRT) programming feature is better than receiving electrical treatment from a CRT device with the standard method of CRT device programming in patients with heart failure. Subjects will receive an already approved CRT pacemaker or defibrillator depending on what the doctor recommends. Approximately 3000 subjects will be enrolled at up to 200 centers around the world.