Medtronic launches ECG belt HF optimization trial
Medtronic (NYSE:MDT) said today it launched a new clinical trial evaluating the use of its ECG belt research system as a diagnostic tool for improving cardiac resynchronization therapy for heart failure patients. The Fridley, Minn.-based company said it has enrolled the first patients in the trial at Des Moines, Iowa’s Mercy Medical Center – West Lakes by principal investigator Dr. Troy Hounshell. “The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits. By pairing CRT with the ECG Belt, we have the potential to provide a more personalized and noninvasive approach to help heart failure patients,” Dr. Hounshell said in a press release. The ECG Belt for CRT Response trial aims to enroll 400 patients at 10 US centers to compare patients treated with both the ECG belt diagnostic and CRT against those treated with standard CRT alone, Medtronic said. Trial investigators will use the ECG belt during the trial to analyze the heart electrical activity through real-time synchronization measurements, as well as during CRT implant to help guide placement of the left ventricular lead, Medtronic said. “Our goal for this study is to give clinicians real-time insights to address each patient’s needs, and to help optimize CRT for heart failure patients,” CRT biz GM Dr. Kweli Thompson said in a prepared statement. Last week, Medtronic said ...
Impulse Dynamics, based in Mt. Laurel, New Jersey, has developed the Optimizer system, a device designed to improve myocardial contractility in patients with heart failure. The system is intended to improve the quality of life of heart failure patien...
Condition: Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy Interventions: Device: conventional CRT; Device: MPP CRT Sponsor: CMC Ambroise Paré Withdrawn
Cardiac resynchronization therapy (CRT) has been associated to left ventricle (LV) remodelling, reduction of functional mitral regurgitation (FMR) and clinical improvement in patients with heart failure and reduced ejection fraction (HFrEF). The prevalence of significant FMR in patients with LV dyssynchrony that are candidate to CRT is up to 40%. Current approach in patients with FMR undergoing CRT consists of re-evaluation of the amount of FMR following a waiting period of at least 3 months after the implant.
Conclusions: CRT-D has higher greater cost-effectiveness across more subgroups in the indicated patient populations against as compared to OPT, ICD and CRT-P, from a US payer perspective. PMID: 32207659 [PubMed - as supplied by publisher]
Condition: Heart Failure Interventions: Procedure: Temporary pacing Study; Radiation: Thoracic CT; Diagnostic Test: Acute hemodynamic study; Diagnostic Test: Non-invasive body surface mapping; Diagnostic Test: Invasive catheter-based mapping Sponsors: Guy's and St Thomas' NHS Foundation Trust; King's College London Recruiting
ConclusionsTherapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.