Clinical trial NCT02698150: Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
Official title: Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Heart Failure
Keywords: Mitral regurgitation
Mitraclip
Remote monitoring
Wearables
Lead sponsor: Azienda Ospedaliero, Ferrarotto Alessi
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-03-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe mitral regurgitation of functional etiology undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life @ 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life @ baseline
timeFrame: Baseline (1 month before Mitraclip implant)
measure: Quality of life @ index procedure (end of the run-in phase)
timeFrame: pre Mitraclip implant
measure: Quality of life @ 1 month
timeFrame: 1 month after Mitraclip implant
Other outcomes:
measure: 6MWT (6-minute walking test)
timeFrame: Baseline
measure: 6MWT (6-minute walking test)
timeFrame: 1 month after Mitraclip implant
measure: 6MWT (6-minute walking test)
timeFrame: 6 months after Mitraclip implant
measure: 6MWT (6-minute walking test)
timeFrame: 12 months after Mitraclip implant
Locations:
city: Catania
country: Italy
facility: Ferrarotto Hospital
Study officials:
affiliation: Ferrarotto Hospital, University of Catania
name: Corrado Tamburino, Professor
role: STUDY_CHAIR
affiliation: Ferrarotto Hospital, University of Catania
name: Carmelo Grasso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ferrarotto Hospital, University of Catania
name: Davide Capodanno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: