ISRCTN96536028
Completed
Not Applicable
REmote Monitoring and evaluation of implantable devices for management of Heart Failure patients
niversity Hospital Southampton NHS Foundation Trust0 sites1,650 target enrollmentJune 27, 2016
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Enrollment
- 1650
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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