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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Mitral Regurgitation
• Intervention / Treatment: Device: HERMES tablet

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.

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

• Study Contact: Name: Corrado Tamburino, Professor; Email: tambucor@unict.it
• Study Contact Backup: Name: Laura Basile; Email: cardiologia.fe@aou.ct.it

Study Locations

• Italy
  • Catania, Italy, 95124
    • Recruiting
    • Ferrarotto Hospital
    • Contact: Corrado Tamburino, MD, PhD; Phone Number: 390957436201; Email: tambucor@unict.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote monitoring; Active group of patients undergoing daily remote monitoring using sensors and wearables	Device: HERMES tablet; Tablet, sensors and wearables for daily collection of clinical data
Control; Control group of patients undergoing standard follow up wth no remote monitoring

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
6MWT (6-minute walking test)	Baseline
6MWT (6-minute walking test)	1 month after Mitraclip implant
6MWT (6-minute walking test)	6 months after Mitraclip implant
6MWT (6-minute walking test)	12 months after Mitraclip implant

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Ferrarotto Alessi
• Collaborators: Abbott Medical Devices
• Investigators: Study Chair: Corrado Tamburino, Professor, Ferrarotto Hospital, University of Catania; Principal Investigator: Carmelo Grasso, MD, Ferrarotto Hospital, University of Catania; Principal Investigator: Davide Capodanno, MD, PhD, Ferrarotto Hospital, University of Catania

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Remote monitoring; Wearables; Mitral regurgitation; Mitraclip
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: HERMES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No