Topic: Cardiovascular
Conditions
Interventions
6 month study of two groups.
Group 1:
Observation so diary entry and Quality of life questionnaires only.
Group 2 (interventional):
Study group download from device using Carelink. Divided into A
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants: 1. Be on stable medical therapy for 6 weeks prior to recruitment 2. Have the ability to independently comprehend and complete QOL Questionnaires 3. Have an episode of New York Heart Association (NHYA) class III heart failure 4. Be on optimal medical therapy 5. Male and female, lower age limit of 16 years Group 2 additional criteria: 6. Must be implanted with a Medtronic Device that has the optivol feature 7. Have had a cardiac device implanted for at least 3 months prior to recruitment 8. Will have had no device related complications
Exclusion criteria
Exclusion criteria: 1. If unable to use the technology due to mental or physical limitations 2. Less than 16 years old 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life is measured uisng the Living with Heart failure Minnesota Life Score and 36-item short form health survey (SF-36) at baseline, 1, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed