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

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ClinicalTrials.gov Identifier: NCT02698150
Recruitment Status : Unknown
Verified September 2017 by Davide Capodanno, Azienda Ospedaliero, Ferrarotto Alessi.
Recruitment status was:  Recruiting
First Posted : March 3, 2016
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Davide Capodanno, Azienda Ospedaliero, Ferrarotto Alessi

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.

Condition or disease Intervention/treatment
Mitral Regurgitation Heart Failure 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System
Study Start Date : March 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2018

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



Primary Outcome Measures :
  1. Quality of life @ 12 months [ Time Frame: 12 months ]
    Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant


Secondary Outcome Measures :
  1. Quality of life @ baseline [ Time Frame: Baseline (1 month before Mitraclip implant) ]
    Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant

  2. Quality of life @ index procedure (end of the run-in phase) [ Time Frame: pre Mitraclip implant ]
    Quality of life assessed with the SF36v2 questionnaire at the time of the Mitraclip procedure

  3. Quality of life @ 1 month [ Time Frame: 1 month after Mitraclip implant ]
    Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant


Other Outcome Measures:
  1. 6MWT (6-minute walking test) [ Time Frame: Baseline ]
  2. 6MWT (6-minute walking test) [ Time Frame: 1 month after Mitraclip implant ]
  3. 6MWT (6-minute walking test) [ Time Frame: 6 months after Mitraclip implant ]
  4. 6MWT (6-minute walking test) [ Time Frame: 12 months after Mitraclip implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698150


Contacts
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Contact: Corrado Tamburino, Professor tambucor@unict.it
Contact: Laura Basile cardiologia.fe@aou.ct.it

Locations
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Italy
Ferrarotto Hospital Recruiting
Catania, Italy, 95124
Contact: Corrado Tamburino, MD, PhD    390957436201    tambucor@unict.it   
Sponsors and Collaborators
Azienda Ospedaliero, Ferrarotto Alessi
Abbott Medical Devices
Investigators
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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
Additional Information:

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Responsible Party: Davide Capodanno, Professor, Azienda Ospedaliero, Ferrarotto Alessi
ClinicalTrials.gov Identifier: NCT02698150    
Other Study ID Numbers: HERMES
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Davide Capodanno, Azienda Ospedaliero, Ferrarotto Alessi:
Mitral regurgitation
Mitraclip
Remote monitoring
Wearables
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases