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

A

Azienda Ospedaliero, Ferrarotto Alessi

Status

Unknown

Conditions

Mitral Regurgitation
Heart Failure

Treatments

Device: HERMES tablet

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02698150
HERMES

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 2 patient groups

Remote monitoring
Description:
Active group of patients undergoing daily remote monitoring using sensors and wearables
Treatment:
Device: HERMES tablet
Control
Description:
Control group of patients undergoing standard follow up wth no remote monitoring

Trial contacts and locations

1

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Central trial contact

Corrado Tamburino, Professor; Laura Basile

Data sourced from clinicaltrials.gov

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