Heart Failure Clinical Trial
— HERMESOfficial title:
Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | October 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ferrarotto Hospital | Catania |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Ferrarotto Alessi | Abbott Vascular |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 6MWT (6-minute walking test) | Baseline | ||
Other | 6MWT (6-minute walking test) | 1 month after Mitraclip implant | ||
Other | 6MWT (6-minute walking test) | 6 months after Mitraclip implant | ||
Other | 6MWT (6-minute walking test) | 12 months after Mitraclip implant | ||
Primary | Quality of life @ 12 months | Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant | 12 months | |
Secondary | Quality of life @ baseline | Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant | Baseline (1 month before Mitraclip implant) | |
Secondary | 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 | |
Secondary | Quality of life @ 1 month | Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant | 1 month after Mitraclip implant |
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