The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating (burning heart tissue using heat energy) your symptomatic, paroxysmal (starts and stops on its own) atrial fibrillation (irregular heart beat in upper chambers of heart) that is not effectively treated with medication. Participation in the study will last about 12 months from the time of the ablation procedure. Participants will be asked to complete follow-up visits at 7-days (phone call visit), 5 weeks (phone call visit) 3-months (in person visit), 6-months (in person visit), and 12-months (in-person visit). Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).
This study involves individuals who have been diagnosed with heart failure, a condition where the heart does not pump blood as well as it should. For this study, a new software program called ALLEVIATE-HF will be studied to see if the software program can help predict worsening heart failure symptoms. The software program will be put onto a medical device called the Reveal LINQ Insertable Cardiac Monitoring (ICM) System. Some participants may already have the Reveal LINQ ICM. If a participant does not already have a Reveal LINQ ICM, then the device will be inserted under the skin. The ALLEVIATE-HF software will help the device identify problems related to heart failure. The device will collect data such as the subjects heart rate and activity level. The information gathered by this system will help the study doctor/healthcare provider and the study team understand an individual subject's risk of having a heart failure event (worsening heart failure symptoms requiring additional treatment or hospitalization) so that steps can be taken to manage their heart failure.
The study will last at least 7 months but may last up to 3 years. There will be at least 2 but up to 4 visits during the study.
The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:
• Group 1 – About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
• Group 2 – About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
• Group 3 – About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.
The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. An arrhythmia is a problem with the rate or rhythm of the heartbeat. The purpose of the study is to see whether an investigational medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm. Every participant will receive the same treatment, radiofrequency (RF) ablation, for atrial fibrillation with the DiamondTemp Ablation System. The results of this study may be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA.