Mitral RegurgitationGIOTTONCT03521921
GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)
An observational study of Mitral Regurgitation, run by IRCCS Policlinico S. Donato at 20 sites in Italy.
Trial summary
The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are suitable for patients with low or moderate surgical risk, thus many patients are denied… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Mitraclip
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 20 sitesItaly
- Study dates
- 1 Feb 2016to 9 Sep 2025
- How long will I take part?
- 5 Years
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any subject who already received or deemed suitable and selected by the site to receive the Mitraclip treatment, in accordance with all applicable device Instructions For Use, should be considered for entry into this study. Eligibility will be documented on the inclusion/exclusion criteria sheet. Subjects who meet the eligibility criteria and have signed and dated the Informed Consent Form and actually undergone / undergo a Mitraclip implant procedure are considered enrolled in the study.
Who may be able to join
- Patients who are eligible for Mitraclip device according to current national and international guidelines (and their future revisions) and per investigator evaluation;
- Patients who are willing and capable of providing informed consent, participating in all Follow-ups associated with this clinical investigation at an approved clinical investigational center;
- More specifically patients inclusion criteria are in line with the indications for use detailed in the IFU in particular, patients have to meet the following inclusions criteria
- Symptomatic severe (4+) MR, or 3+ MR and NYHA > II.
- Mitral valve anatomy should be suitable for MitraClip.
- Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related data collection.
Who cannot join
- Valve anatomy is unsuitable for MitraClip therapy as per the indication in the Mitraclip IFU
- Currently participating in the study of an investigational drug or device
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
ASST Papa Giovanni XXIII
Bergamo
Fondazione Poliambulanza
Brescia
Spedali Civili
Brescia
Pineta Grande
Castel Volturno
Ospedale Ferrarotto
Catania
Cardiologia Università Magna Graecia
Catanzaro
Maria Cecilia Hospital
Cotignola
Ospdale dell'Angelo ULSS12 Veneziana
Mestre
Centro Cardiologico Monzino
Milan
Ospedale San Raffaele - Cardiochirurgia
Milan
Ospedale San Raffaele - Emodinamica
Milan
AORN Dei Colli "V. Monaldi - Cardiologia Interventistica
Naples
AORN dei Colli "V. Monaldi" - Emodinamica
Naples
UOC cardiologia Università di Padova
Padova
Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliero Universitaria Pisana
Pisa
Azienda Ospedaliera San Camillo Forlanini
Roma
IRCCS Humanitas
Rozzano
AOU San Giovanni di Dio e Ruggi D'Aragona
Salerno
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
About this study
The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are suitable for patients with low or moderate surgical risk, thus many patients are denied surgery because of unfavorable risk-benefit balance. The EuroHeart Surveyconducted by the ESC showed that one half of patients with severe mitral regurgitation were denied surgical treatment because they were felt to be at too high risk for surgery by the referring physician. Such patients are usually elderly and have co-morbidities. Thus, there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform mitral repair in a minimally-invasive fashion and possibly without cardiopulmonary bypass. The landmark EVEREST II trial randomized 279 patients with grade 3/4 MR in a 2:1 fashion to MitraClip® or surgical repair/replacement showing a lower major adverse event rate at 30-days in the MitraClip® group (15.0% vs. 48%; superiority p<0.001), mainly driven by the need for blood transfusion with surgery, and the primary efficacy endpoint of freedom from the combined outcome of death, new surgery for mitral valve dysfunction or the occurrence of >2+ MR was achieved in 55% vs. 73% (non-inferiority p=0.007). However, this study has included a highly selected patient cohort in which patients with significant surgical risk have been excluded. More recently, Multinational (ACCESS-EU, EVEREST-High Risk) and national registries (TRAMI, SWISS) have shown safety and efficacy in the real world experience. Patients currently treated are high risk, elderly, with comorbidities and mainly affected by FMR. There is need for an Italian registry, since Italy has produced the second largest volume of transcathetermitral procedures in the world after Germany. The present registry is designed to collect real world clinical data on early and long-term outcomes following percutaneous mitral regurgitation therapy in consecutive patients undergoing transcatheter procedures in Hospitals linked to the GISE database.
Read the detailed description
The main objective is to achieve demographic and outcome data and identify predictors of clinical success, according to real-world Italian data. In addition the registry is designed to obtain health economic data to support reimbursement strategies in Italy. The study is focusing on MITRACLIP therapy since this is the leading method for treatment currently in Italy.
All consecutive patients undergone/ undergoing a transcatheter mitral valve repair, with Mitraclip device, will be enrolled to reach a number of about 1100 patients in about 22 hospitals. Data analysis will be conducted at the end of follow-up period of the last enrolled patient. . Additional data analysis will be done according to specific topics, approved by the scientific board of GISE and or on Ethic Committees requests. The population of the study is patients undergoing/undergone a transcatheter mitral valve repair procedure in hospitals linked to the GISE network. More specifically Patients from the investigators' general Mitraclip treatment patient population will be eligible to be enrolled in this Registry. Patients should meet all the inclusion criteria and none of the exclusion criteria. Retrospective enrolments are allowed if available data are in line with the Study requirements and the patients can give their consent to be enrolled in the study informed consent process.
Follow-up visit will be performed at 30 days, 1 year and up to 5 years after the procedure.
- Conditions
- Mitral Regurgitation
- Being tested
- Mitraclip
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraclipDevice
Edge-to edge mitral valve repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
cardiovascular and non-cardiovascular death events with specificed cause.
Measured: From index procedure up to 5 years
Secondary outcomes (2)
MACCE
cardiovascular and cerebrovascular major adverse events.
Measured: From index procedure up to 5 years
Reduction of MR
Reduction of MR evaluated with a scale 1 to 4
Measured: Within 7 days after procedure and 1 year and up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Feb 2016
- Primary completion1 Feb 2021
- Study completion9 Sep 2025 (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.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Bedogni, IRCCS Policlinico S. Donato
- Investigators
- Francesco Bedogni, Dr., Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521921
- Sponsor's protocol ID
- GISE/01/2014/GIOTTO
- Acronym
- GIOTTO
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be reviewed by a Data Safety and Monitoring Board. The Data Safety and Monitoring Board will be also responsible for: * Determining whether information collected are sufficient to address the objectives * Recommending modifications to the statistical analysis plan to address additional research questions based on review of the data
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)
- ClinicalTrials.gov ID
- NCT03521921
- Acronym / sponsor ID
- GIOTTO / GISE/01/2014/GIOTTO
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 11 May 2018 (actual)
- 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.
The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are suitable for patients with low or moderate surgical risk, thus many patients are denied surgery because of unfavorable risk-benefit balance. The EuroHeart Surveyconducted by the ESC showed that one half of patients with severe mitral regurgitation were denied surgical treatment because they were felt to be at too high risk for surgery by the referring physician. Such patients are usually elderly and have co-morbidities. Thus, there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform mitral repair in a minimally-invasive fashion and possibly without cardiopulmonary bypass. The landmark EVEREST II trial randomized 279 patients with grade 3/4 MR in a 2:1 fashion to MitraClip® or surgical repair/replacement showing a lower major adverse event rate at 30-days in the MitraClip® group (15.0% vs. 48%; superiority p<0.001), mainly driven by the need for blood transfusion with surgery, and the primary efficacy endpoint of freedom from the combined outcome of death, new surgery for mitral valve dysfunction or the occurrence of >2+ MR was achieved in 55% vs. 73% (non-inferiority p=0.007). However, this study has included a highly selected patient cohort in which patients with significant surgical risk have been excluded. More recently, Multinational (ACCESS-EU, EVEREST-High Risk) and national registries (TRAMI, SWISS) have shown safety and efficacy in the real world experience. Patients currently treated are high risk, elderly, with comorbidities and mainly affected by FMR. There is need for an Italian registry, since Italy has produced the second largest volume of transcathetermitral procedures in the world after Germany. The present registry is designed to collect real world clinical data on early and long-term outcomes following percutaneous mitral regurgitation therapy in consecutive patients undergoing transcatheter procedures in Hospitals linked to the GISE database.
Detailed description
The main objective is to achieve demographic and outcome data and identify predictors of clinical success, according to real-world Italian data. In addition the registry is designed to obtain health economic data to support reimbursement strategies in Italy. The study is focusing on MITRACLIP therapy since this is the leading method for treatment currently in Italy.
All consecutive patients undergone/ undergoing a transcatheter mitral valve repair, with Mitraclip device, will be enrolled to reach a number of about 1100 patients in about 22 hospitals. Data analysis will be conducted at the end of follow-up period of the last enrolled patient. . Additional data analysis will be done according to specific topics, approved by the scientific board of GISE and or on Ethic Committees requests. The population of the study is patients undergoing/undergone a transcatheter mitral valve repair procedure in hospitals linked to the GISE network. More specifically Patients from the investigators' general Mitraclip treatment patient population will be eligible to be enrolled in this Registry. Patients should meet all the inclusion criteria and none of the exclusion criteria. Retrospective enrolments are allowed if available data are in line with the Study requirements and the patients can give their consent to be enrolled in the study informed consent process.
Follow-up visit will be performed at 30 days, 1 year and up to 5 years after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any subject who already received or deemed suitable and selected by the site to receive the Mitraclip treatment, in accordance with all applicable device Instructions For Use, should be considered for entry into this study. Eligibility will be documented on the inclusion/exclusion criteria sheet. Subjects who meet the eligibility criteria and have signed and dated the Informed Consent Form and actually undergone / undergo a Mitraclip implant procedure are considered enrolled in the study.
Key inclusion criteria (6 listed)
- Patients who are eligible for Mitraclip device according to current national and international guidelines (and their future revisions) and per investigator evaluation;
- Patients who are willing and capable of providing informed consent, participating in all Follow-ups associated with this clinical investigation at an approved clinical investigational center;
- More specifically patients inclusion criteria are in line with the indications for use detailed in the IFU in particular, patients have to meet the following inclusions criteria
- Symptomatic severe (4+) MR, or 3+ MR and NYHA > II.
- Mitral valve anatomy should be suitable for MitraClip.
Key exclusion criteria (3 listed)
- Valve anatomy is unsuitable for MitraClip therapy as per the indication in the Mitraclip IFU
- Currently participating in the study of an investigational drug or device
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
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 |
|---|---|---|
| MitraclipEdge-to edge mitral valve repair | Device | – |
Primary outcome
Mortality
Time frame: From index procedure up to 5 years
cardiovascular and non-cardiovascular death events with specificed cause.
2 secondary outcomes
MACCE
Time frame: From index procedure up to 5 years
Reduction of MR
Time frame: Within 7 days after procedure and 1 year and up to 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No. The data will be reviewed by a Data Safety and Monitoring Board. The Data Safety and Monitoring Board will be also responsible for: * Determining whether information collected are sufficient to address the objectives * Recommending modifications to the statistical analysis plan to address additional research questions based on review of the data
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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.
Francesco Bedogni, Dr. principal investigator
IRCCS Policlinico S. Donato
20 sites 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, run by IRCCS Policlinico S. Donato at 20 sites 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 6 inclusion and 3 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From index procedure up to 5 years). 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 5 Dec 2023.