Heart Failure, Mitral Regurgitation
Conditions
Keywords
Mitral regurgitation, Mitraclip, Remote monitoring, Wearables
Brief summary
HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system.
Detailed description
The scope of the HERMES study is to investigate whether the information obtained by remote monitoring in patients with severe functional mitral regurgitation who have undergone transcatheter mitral valve edge-to-edge repair with the Mitraclip system may have the potential to guide treatment decisions at follow-up visits, and improve the quality of life. Candidates to the Mitraclip procedure on optimal medical therapy will be offered the opportunity to participate to the study by bringing home a tablet and a series of sensors and wearables to collect daily information on blood pressure, oxygen saturation, weight variation, heart rate, symptoms and compliance to therapy. These variables will be blinded, stored by the tablet and downloaded by the core institution at follow-up visits. Clinicians will be encouraged to use these data to guide their decisions, personalizing drug therapies and follow-up schedules to the individual patient's need. Patients that during the run-in phase (from enrollment to 30+-7 days) will have used the tablet for \>66% of the days will undergo the Mitraclip procedure and continue to keep the tablet for up to 12 months (active group). Patients that during the run-in phase (from enrollment to 30+-7 days) will have not used the tablet for \>66% of the days, will continue the study as a control group. Predefined clinical follow up assessments for collection of study endpoints will be at 1 month post Mitraclip, 6 months post Mitraclip and 12 months post Mitraclip. Quality of life, assessed by means of the SF36v2 questionnaire, will be assessed at enrollment, pre Mitraclip, at 1 month after Mitraclip and at 12 months after Mitraclip. A series of secondary endpoints, including 6MWT assessments and consumption of resources will be also assessed.
Interventions
DEVICEHERMES tablet
Tablet, sensors and wearables for daily collection of clinical data
Sponsors
Abbott Medical Devices
Azienda Ospedaliero, Ferrarotto Alessi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic while on optimal medical therapy (NYHA Class III-IV) * Mitral regurgitation of functional etiology * Suitable Mitraclip candidate * Life expectancy \>12 months
Exclusion criteria
* Mitral regurgitation of primary etiology * Refusal to sign the informed consent * Dementia or neurological disorders that prevent the proper use of the tablet * Inability to use the tablet, the sensors and/or the wearables, even with the assistance of family members * Expected non-compliance with follow-up visits * End-stage chronic kidney disease on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life @ 12 months | 12 months | Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life @ baseline | Baseline (1 month before Mitraclip implant) | Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant |
| Quality of life @ index procedure (end of the run-in phase) | pre Mitraclip implant | Quality of life assessed with the SF36v2 questionnaire at the time of the Mitraclip procedure |
| Quality of life @ 1 month | 1 month after Mitraclip implant | Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant |
Other
| Measure | Time frame |
|---|---|
| 6MWT (6-minute walking test) | Baseline |
Countries
Italy
Contacts
Primary ContactCorrado Tamburino, Professor
Backup ContactLaura Basile
Outcome results
None listed