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

Heart Failure Clinical Trial

— HERMES  

Official title:

Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698150
• Other study ID #: HERMES
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2016
• Last updated: September 8, 2017
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2017
• Source: Azienda Ospedaliero, Ferrarotto Alessi
• Contact: Corrado Tamburino, Professor
• Email: tambucor[@]unict.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• HERMES tablet
Tablet, sensors and wearables for daily collection of clinical data

Locations

Country	Name	City	State
Italy	Ferrarotto Hospital	Catania

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Ferrarotto Alessi	Abbott Vascular

Country where clinical trial is conducted

Italy, 

Outcome

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