Mitral RegurgitationHERMESNCT02698150
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
An observational study of Mitral Regurgitation and Heart Failure, run by Azienda Ospedaliero, Ferrarotto Alessi at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Heart Failure
- What is being tested?
- HERMES tablet
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Oct 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe mitral regurgitation of functional etiology undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system
Who may be able to join
- Symptomatic while on optimal medical therapy (NYHA Class III-IV)
- Mitral regurgitation of functional etiology
- Suitable Mitraclip candidate
- Life expectancy >12 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Corrado Tamburino, Professor contact
Laura Basile contact
Italy1 site, 1 recruiting
- Recruiting
Ferrarotto Hospital
Catania, 95124
Corrado Tamburino, MD, PhD, 390957436201, tambucor@unict.it
About this study
Official title: 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.
Read the 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
- Being tested
- HERMES tablet
- Keywords
- Mitral regurgitation, Mitraclip, Remote monitoring, Wearables
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERMES tabletDevice
Tablet, sensors and wearables for daily collection of clinical data
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring | Active group of patients undergoing daily remote monitoring using sensors and wearables Receives: Device: HERMES tablet | |
| Control | Control group of patients undergoing standard follow up wth no remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life @ 12 months
Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant
Measured: 12 months
Secondary outcomes (3)
Quality of life @ baseline
Quality of life assessed with the SF36v2 questionnaire at 1 month before Mitraclip implant
Measured: 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
Measured: pre Mitraclip implant
Quality of life @ 1 month
Quality of life assessed with the SF36v2 questionnaire at 1 month after Mitraclip implant
Measured: 1 month after Mitraclip implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Ferrarotto Alessi
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Davide Capodanno, Azienda Ospedaliero, Ferrarotto Alessi
- Investigators
- Corrado Tamburino, Professor, Study chair, Ferrarotto Hospital, University of CataniaCarmelo Grasso, MD, Principal investigator, Ferrarotto Hospital, University of CataniaDavide Capodanno, MD, PhD, Principal investigator, Ferrarotto Hospital, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698150
- Sponsor's protocol ID
- HERMES
- Acronym
- HERMES
- Status last verified
- Sep 2017
- First submitted
- 26 Feb 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remote Monitoring in Patients With Functional Mitral Regurgitation Undergoing Transcatheter Mitral Valve Edge-to-edge Repair With the Mitraclip System
- ClinicalTrials.gov ID
- NCT02698150
- Acronym / sponsor ID
- HERMES / HERMES
- Conditions
- Mitral Regurgitation, Heart Failure
- Keywords
- Mitral regurgitation, Mitraclip, Remote monitoring, Wearables
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Ferrarotto AlessiUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring | – | Device: HERMES tabletActive group of patients undergoing daily remote monitoring using sensors and wearables |
| Control | – | –Control group of patients undergoing standard follow up wth no remote monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe mitral regurgitation of functional etiology undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system
Key inclusion criteria (4 listed)
- Symptomatic while on optimal medical therapy (NYHA Class III-IV)
- Mitral regurgitation of functional etiology
- Suitable Mitraclip candidate
- Life expectancy >12 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERMES tabletTablet, sensors and wearables for daily collection of clinical data | Device | Remote monitoring |
Primary outcome
Quality of life @ 12 months
Time frame: 12 months
Quality of life assessed with the SF36v2 questionnaire at 12 months post Mitraclip implant
3 secondary outcomes
Quality of life @ baseline
Time frame: Baseline (1 month before Mitraclip implant)
Quality of life @ index procedure (end of the run-in phase)
Time frame: pre Mitraclip implant
Quality of life @ 1 month
Time frame: 1 month after Mitraclip implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrado Tamburino, Professor contact
Laura Basile contact
Corrado Tamburino, Professor study chair
Ferrarotto Hospital, University of Catania
Carmelo Grasso, MD principal investigator
Ferrarotto Hospital, University of Catania
Davide Capodanno, MD, PhD principal investigator
Ferrarotto Hospital, University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Heart Failure, run by Azienda Ospedaliero, Ferrarotto Alessi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corrado Tamburino, Professor (tambucor@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life @ 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.