MedPath

Remote monitoring in heart failure patients

Completed
Conditions
Heart failure
Circulatory System
Registration Number
ISRCTN96536028
Lead Sponsor
niversity Hospital Southampton NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
1650
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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