NCT02698150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

February 26, 2016

Last Update Submit

September 8, 2017

Conditions

Mitral RegurgitationHeart Failure

Keywords

Mitral regurgitationMitraclipRemote monitoringWearables

Outcome Measures

Primary Outcomes (1)

  • Quality of life @ 12 months

    Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant

    12 months

Secondary Outcomes (3)

  • Quality of life @ baseline

    Baseline (1 month before Mitraclip implant)

  • Quality of life @ index procedure (end of the run-in phase)

    pre Mitraclip implant

  • Quality of life @ 1 month

    1 month after Mitraclip implant

Other Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (2)

Remote monitoring

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

Device: HERMES tablet

Control

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

Interventions

HERMES tabletDEVICE

Tablet, sensors and wearables for daily collection of clinical data

Remote monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe mitral regurgitation of functional etiology undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system

You may qualify if:

  • Symptomatic while on optimal medical therapy (NYHA Class III-IV)
  • Mitral regurgitation of functional etiology
  • Suitable Mitraclip candidate
  • Life expectancy \>12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferrarotto Hospital

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Corrado Tamburino, Professor

    Ferrarotto Hospital, University of Catania

    STUDY CHAIR

  • Carmelo Grasso, MD

    Ferrarotto Hospital, University of Catania

    PRINCIPAL INVESTIGATOR

  • Davide Capodanno, MD, PhD

    Ferrarotto Hospital, University of Catania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrado Tamburino, Professor

CONTACT

tambucor@unict.it

Laura Basile

CONTACT

cardiologia.fe@aou.ct.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2018

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)