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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System

Conditions
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Mitral Regurgitation, Heart Failure

Intervention / Treatment
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* Device: HERMES tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remote monitoring<br>Active group of patients undergoing daily remote monitoring using sensors and wearables | Device: HERMES tablet<br>* Tablet, sensors and wearables for daily collection of clinical data<br>|
| Control<br>Control group of patients undergoing standard follow up wth no remote monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life @ 12 months | Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life @ baseline | Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant | Baseline (1 month before Mitraclip implant) | 
| Quality of life @ index procedure (end of the run-in phase) | Quality of life assessed with the SF36v2 questionnaire at the time of the Mitraclip procedure | pre Mitraclip implant | 
| Quality of life @ 1 month | Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant | 1 month after Mitraclip implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral regurgitation, Mitraclip, Remote monitoring, Wearables