Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
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.
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.
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