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

NCT ID: NCT02698150

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-10-31

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.

Conditions

Mitral Regurgitation; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Remote monitoring

Active group of patients undergoing daily remote monitoring using sensors and wearables

HERMES tablet

Intervention Type: DEVICE

Tablet, sensors and wearables for daily collection of clinical data

Control

Control group of patients undergoing standard follow up wth no remote monitoring

No interventions assigned to this group

Interventions

HERMES tablet

Tablet, sensors and wearables for daily collection of clinical data

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Azienda Ospedaliero, Ferrarotto Alessi

OTHER

Sponsor Role: lead

Responsible Party

Davide Capodanno

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corrado Tamburino, Professor

Role: STUDY_CHAIR

Ferrarotto Hospital, University of Catania

Carmelo Grasso, MD

Role: PRINCIPAL_INVESTIGATOR

Ferrarotto Hospital, University of Catania

Davide Capodanno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ferrarotto Hospital, University of Catania

Locations

Ferrarotto Hospital

Catania, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Corrado Tamburino, Professor

Role: CONTACT

tambucor@unict.it

Laura Basile

Role: CONTACT

cardiologia.fe@aou.ct.it

Facility Contacts

Corrado Tamburino, MD, PhD

Role: primary

tambucor@unict.it

390957436201

Other Identifiers

HERMES

Identifier Type: -

Identifier Source: org_study_id