Mitral Valve RegurgitationNCT05455489
GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
An observational study of Mitral Valve Regurgitation, run by Fondazione GISE Onlus at 1 site in Italy.
Trial summary
The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- How many people
- 264 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2023to 1 Aug 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing/undergone to TEER procedure with MitraClip G4 in selected hospitals linked to the GISE network. Patients should meet all the inclusion criteria and none of the exclusion criteria; such criteria will identify a selected all comers ("more-comers") population which includes the vast majority of patients treated with MitraClip in daily practice. 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. Patients who don't meet one or more of the inclusion criteria or met at least one exclusion criteria are excluded from the study; however, a selected list of baseline/procedural features and follow-up data will be recorded for excluded patients.
Who may be able to join
- SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND
- Left Ventricular End-Systolic Dimension <70 mm
- Mitral Valve area > 4 cmq
- Left ventricular ejection fraction ≥20%
- NYHA functional class II, III, ambulatory IV
- brain natriuretic peptide BNP ≥300 pg/ml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg/ml and/or at least one hosp for HF (Heart failure) in the 12 months prior to enrollment
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- Age 18 years or older
- Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF
- Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND
- Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device
- MV area > 4 cm2
- NYHA functional class > II
- Age 18 years or older
- Local HT decision In case of patients with a coexistence of both etiologies, they will be assigned to a subgroup based on the prevailing mechanism.
- THE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from the criteria recommended by the American Society of Echocardiography 2003 Guidelines and based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR was 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them. For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on the integrative evaluation of multiple parameters recommended by the The American Society of Echocardiography (ASE)
Who cannot join
- Significant right ventricular disfunction (TAPSE<15 mm and/or S'<8cm/s)
- Systolic pulmonary artery > 70 mmHg with irreversible precapillary pulmonary hypertension
- Severe TR Tricuspid valve regurgitation
- Hemodynamic instability/NYHA IV
- Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia
- Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
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- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies
- CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days
- Life expectancy <12 months due to non-cardiac conditions
- Active infections
- Advanced HF (ESC/HFA Heart Failure Association Criteria) or Bridge tp to HTx/LVAD (left ventricular assist device)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milano, 20097
Federica Rossi, +390252774987, Federica.Rossi@grupposandonato.it
Antonio Popolo Rubbio, MD
About this study
Official title: The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.
- Conditions
- Mitral Valve Regurgitation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| FUNCTIONAL MR | Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy | |
| DEGENERATIVE MR | Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of participants with a mitral regurgitation (MR)
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
Measured: at 30 days
percentage of participants with a mitral regurgitation (MR)
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
Measured: at 1 year
Secondary outcomes (6)
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 30 days
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 1 year
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 2 years
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 3 years
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 4 years
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start25 Jan 2023
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- 264 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione GISE Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455489
- Sponsor's protocol ID
- GISE_GIOTTO4
- Status last verified
- Mar 2024
- First submitted
- 4 Jul 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
- ClinicalTrials.gov ID
- NCT05455489
- Acronym / sponsor ID
- GISE_GIOTTO4
- Conditions
- Mitral Valve Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Fondazione GISE OnlusUniversity, hospital or other
- Collaborators
- University of Padova, Abbott
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 13 Jul 2022 (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 aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FUNCTIONAL MR | – | –Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy |
| DEGENERATIVE MR | – | –Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing/undergone to TEER procedure with MitraClip G4 in selected hospitals linked to the GISE network. Patients should meet all the inclusion criteria and none of the exclusion criteria; such criteria will identify a selected all comers ("more-comers") population which includes the vast majority of patients treated with MitraClip in daily practice. 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. Patients who don't meet one or more of the inclusion criteria or met at least one exclusion criteria are excluded from the study; however, a selected list of baseline/procedural features and follow-up data will be recorded for excluded patients.
Key inclusion criteria (15 listed)
- SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND
- Left Ventricular End-Systolic Dimension <70 mm
- Mitral Valve area > 4 cmq
- Left ventricular ejection fraction ≥20%
- NYHA functional class II, III, ambulatory IV
Key exclusion criteria (11 listed)
- Significant right ventricular disfunction (TAPSE<15 mm and/or S'<8cm/s)
- Systolic pulmonary artery > 70 mmHg with irreversible precapillary pulmonary hypertension
- Severe TR Tricuspid valve regurgitation
- Hemodynamic instability/NYHA IV
- Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of participants with a mitral regurgitation (MR)
Time frame: at 30 days
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
percentage of participants with a mitral regurgitation (MR)
Time frame: at 1 year
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
6 secondary outcomes
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 30 days
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 1 year
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 2 years
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 3 years
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 4 years
composite of all-cause death and hospitalization for heart failure (HF),
Time frame: at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Italy
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 Valve Regurgitation, run by Fondazione GISE Onlus 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 15 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with a mitral regurgitation (MR) (time frame: at 30 days). The study lists 2 primary outcomes in all. 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 4 Mar 2024.