REmote Monitoring and evaluation of implantable devices for management of Heart Failure patients

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 1,650 人开始时间: 2016年6月27日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•1.Participants will all have received an Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy-Pacemaker (CRT-P) or Cardiac Resynchronisation Therapy-Defibrillator (CRT-D) at least six months previously, for the treatment and monitoring of chronic heart failure
•2.Be on stable medical therapy for CHF for 6 weeks prior to recruitment
•3.Will have the ability to independently comprehend and complete Quality of Life Questionnaires
•4. Will have the ability to give informed consent
•5. Will be on optimal medical therapy according to the treating physician, working to NICE Guidelines
•6. Will have had their device programmed to give optimal therapy according to the treating physician
•7. Will have symptomatic heart failure (i.e. NYHA Class II to IV) documented at the time of study enrolment
•8. Will be at least 30 days post any device change or lead replacement procedure
•9. Will be at least 3 months post any cardiac surgical procedure
•10. Will be at least 3 months post acute myocardial infarction

•1. Unable to use the technology due to mental or physical limitations
•2. Less than 18 years old
•3. Pregnancy
•4. On a heart transplant list
•5. Life expectancy of < one year (non cardiovascular related) in the opinion of the treating physician
•6. Current device related complications, e.g. wound infection or haematoma, lead fracture
•7. Device implanted less than 6 months previously
•8. Patients unable to understand written and spoken English.

发起方

niversity Hospital Southampton NHS Foundation Trust