Tricuspid Valve RegurgitationTRIBUTENCT05767645
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
A study testing Mistral Procedure in people with Tricuspid Valve Regurgitation, run by Mitralix at 1 site in Israel.
Trial summary
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation
- What is being tested?
- Mistral Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jun 2021to 1 Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
- Subject is ≥ 18 years of age or legal age in host country
- Minimum of moderate functional or degenerative tricuspid regurgitation:
- Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion.
- Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion
- Subject has left ventricular ejection fraction (LVEF) >20 %
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- The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
- Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible.
- Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure.
- As determined by the center heart team, the Mistral is the suitable treatment option.
Who cannot join
- Tricuspid Stenosis >mild
- Tricuspid Sub valvular calcification or calcification of the chordae.
- Subjects with Mitral valve severe stenosis and/or severe regurgitation.
- Previous tricuspid valve repair or replacement that would interfere with placement of Mistral
- Subjects with severe, uncontrolled hypertension.
- Subjects, which need to undergo an emergency surgery.
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- Subject is currently participating in another clinical trial that has not yet completed its primary endpoints.
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 30 days.
- Subject has a history of a myocardial infarction (MI) in the past 30 days.
- Subject has had a percutaneous coronary intervention (PCI), within the last 30 days before procedure.
- Subject with active endocarditis.
- Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits.
- Subject has hemodynamic instability requiring inotropic or mechanical support.
- Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication.
- Subject is on chronic dialysis.
- Bleeding disorders or hypercoagulable state.
- In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
- Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
- Subject has a known allergy to Nitinol alloys, 316L\304 stainless steel.
- Pregnant or lactating women.
- Patients being dependent upon the sponsor or upon the investigator or upon the investigational site.
- According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure).
- Contraindication for TEE (transesophageal echocardiography) including trans-gastric views.
- Life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Mary Israelson, +97235028699, MaryI@wmc.gov.il
Ronen Rubinshtein
About this study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Read the detailed description
The main objectives of this study are to evaluate safety and effectiveness of the Mistral implant for the percutaneous treatment of patients with symptomatic moderate or greater tricuspid regurgitation (TR) who are at high risk for tricuspid valve surgery.
Primary endpoints:
- Safety: Incidence of Major Device Related Adverse Events (MDRAE). [Time frame: 6 months].
- Efficacy: Echocardiographic improvement in TR severity of at least 1 grade [Time Frame: 30 days].
Secondary endpoints:
Safety:
- Incidence of Major Device Related Adverse Events (MDRAE). [Time Frame: 1, 6, 12, and 24 months].
- Incidence of device or procedure related serious adverse events [Time Frame: 30 days].
Efficacy:
- Change in TR grade by Echocardiography [Time Frame: 1, 6, 12, and 24 months over baseline].
- Conditions
- Tricuspid Valve Regurgitation
- Being tested
- Mistral Procedure
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mistral ProcedureDevice
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
| Study group | Role | What they receive |
|---|---|---|
| Mistral device | Experimental | The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. Receives: Device: Mistral Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Safety
Incidence of Major Device Related Adverse Events (MDRAE).
Measured: 6 months
Secondary outcomes (3)
Safety - Incidence of Major Device Related Adverse Events
Incidence of Major Device Related Adverse Events (MDRAE).
Measured: 1, 6, 12, and 24 months
Safety - Incidence of device or procedure related serious adverse events
Incidence of device or procedure related serious adverse events
Measured: 30 days
Effectiveness TR
- Change in TR grade by Echocardiography
Measured: 1, 6, 12, and 24 months over baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start21 Jun 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitralix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronen Rubinshtein, Principal investigator, Wolfson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767645
- Sponsor's protocol ID
- CL-1048
- Acronym
- TRIBUTE
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
- ClinicalTrials.gov ID
- NCT05767645
- Acronym / sponsor ID
- TRIBUTE / CL-1048
- Conditions
- Tricuspid Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- MitralixIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 14 Mar 2023 (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 Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Detailed description
The main objectives of this study are to evaluate safety and effectiveness of the Mistral implant for the percutaneous treatment of patients with symptomatic moderate or greater tricuspid regurgitation (TR) who are at high risk for tricuspid valve surgery.
Primary endpoints:
- Safety: Incidence of Major Device Related Adverse Events (MDRAE). [Time frame: 6 months].
- Efficacy: Echocardiographic improvement in TR severity of at least 1 grade [Time Frame: 30 days].
Secondary endpoints:
Safety:
- Incidence of Major Device Related Adverse Events (MDRAE). [Time Frame: 1, 6, 12, and 24 months].
- Incidence of device or procedure related serious adverse events [Time Frame: 30 days].
Efficacy:
- Change in TR grade by Echocardiography [Time Frame: 1, 6, 12, and 24 months over baseline].
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mistral device | Experimental | Device: Mistral ProcedureThe Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
- Subject is ≥ 18 years of age or legal age in host country
- Minimum of moderate functional or degenerative tricuspid regurgitation:
- Subject has left ventricular ejection fraction (LVEF) >20 %
- The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
Key exclusion criteria (24 listed)
- Tricuspid Stenosis >mild
- Tricuspid Sub valvular calcification or calcification of the chordae.
- Subjects with Mitral valve severe stenosis and/or severe regurgitation.
- Previous tricuspid valve repair or replacement that would interfere with placement of Mistral
- Subjects with severe, uncontrolled hypertension.
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 |
|---|---|---|
| Mistral ProcedureThe Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. | Device | Mistral device |
Primary outcome
• Safety
Time frame: 6 months
Incidence of Major Device Related Adverse Events (MDRAE).
3 secondary outcomes
Safety - Incidence of Major Device Related Adverse Events
Time frame: 1, 6, 12, and 24 months
Safety - Incidence of device or procedure related serious adverse events
Time frame: 30 days
Effectiveness TR
Time frame: 1, 6, 12, and 24 months over baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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.
Ronen Rubinshtein principal investigator
Wolfson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mistral Procedure in people with Tricuspid Valve Regurgitation, run by Mitralix at 1 site in Israel.
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 10 inclusion and 24 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 15 Mar 2023. 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 Israel. 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 Dana Yaron (+972542330022, dana@mitralix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Safety (time frame: 6 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 15 Mar 2023.