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Tricuspid Valve RegurgitationNCT04071652

MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

A study testing Mistral implantation in people with Tricuspid Valve Regurgitation, run by Mitralix at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesIsrael
Study dates
8 Aug 2017to 28 Feb 2023
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

  • Subject has given signed study Informed Consent for participation prior to procedure.
  • Subject is ≥ 18 years of age or legal age in host country
  • Subject is willing and able to comply with all required follow-up evaluations
  • Genders eligible for the study: Both genders
  • Subject has TR of grade 3+ or more
  • Subject has left ventricular ejection fraction (LVEF) >20 %
Show all 10Show fewer
  • Subject is of functional class 2 or more (NYHA)
  • The subject is high risk to undergo TV surgery as assessed and consented by a cardiac surgeon and an interventional cardiologist at the site (center heart team), and according to ESC/EACTS guidelines on the management of valvular heart disease.
  • Patients with Jugular and/or Femoral veins enabling catheterization with 12Fr catheters
  • Life expectancy ≥ 1 year

Who cannot join

  • Tricuspid Stenosis >mild
  • Tricuspid Subvalvular calcification or calcification of the chordae.
  • Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
  • Subject has a history of a myocardial infarction (MI) in the past 3 months
  • Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 7 days of the index procedure
  • Subject has a history of, or has active endocarditis
Show all 23Show fewer
  • Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits
  • Subject is in acute pulmonary edema.
  • Subject has hemodynamic instability requiring inotropic or mechanical support.
  • Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication
  • Subject has renal insufficiency as evidenced by a serum Creatinine > 3.0mg/dL.
  • Subject has ongoing infection or sepsis
  • Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy)
  • Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months prior to the index procedure
  • Subject requires emergency surgery for any reason
  • 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.
  • Subject has a known contrast media allergy
  • Presence of high degree atrio-ventricular block (2nd or 3rd degree A-V block), or the presence of tri-fascicular block
  • 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) and has a life expectancy of less than 1 year.
  • Contraindication for treatment with dual antiplatelet therapy for at least 3 months
  • Contraindication for TEE including trans-gastric views.

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Haddassah

    Jerusalem, Kiryat Hadassah, 91120

  • The Chain Sheba Medical Center at Tel HaShomer

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

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 study is designed to clinically demonstrate device acute safety and technical performance (Primary Endpoints) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).

The main objectives of the study are :

  • Evaluate the Acute safety of the implanted Mistral device post procedure and at 30 day follow up period.
  • Evaluate the long term Safety of the device.
  • Demonstrate effectiveness of the Mistral device in reducing TR.

Primary endpoints:

  • Safety: Acute safety. Rate of device related SAE including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event. At discharge and 30 days.
  • Performance: Mistral Implantation rate of technical success (defined as successful device implantation with grasped chords from at least two leaflets.).

Secondary endpoints:

  • Safety: Safety at 3, 6 and 12 months. Rate of device related SAEs at 3, 6 and 12 months.
  • Effectiveness: TR reduction post-procedure, at discharge and 30 days, 3 and 6 months. Improved NYHA class, 6MWTdistance and KCCQ (quality of life) at 30 days, 3 and 6 months.

Relevant only for patients 11-20:

  • Safety: Safety at 3, 6, 12 and 24 months. Rate of device related SAEs at 3, 6, 12 and 24 months.
  • Effectiveness: TR reduction post-procedure, at discharge and 30 days, 3, 6, 12 and 24 months. Improved NYHA class, 6MWT distance and KCCQ (quality of Life) at 30 days, 3, 6, 12 and 24 months.
Being tested
Mistral implantation
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 implantationDevice

    Mistral implant is implanted in the Tricuspid valve

Study groups in NCT04071652
Study groupRoleWhat they receive
MistralExperimentalThe 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 implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Acute safety. Rate of device related SAE

    including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event

    Measured: Until hospital discharge - up to 5 days post procedure day

  2. Safety: Acute safety. Rate of device related SAE

    including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event

    Measured: At 30 days post procedure

  3. Performance: Mistral Implantation rate of technical success

    defined as successful device implantation with grasped chords from at least two leaflets

    Measured: Procedure

Secondary outcomes (26)

  1. Safety: Rate of device related SAE

    Measured: at 3 months post procedure

  2. Safety: Rate of device related SAE

    Measured: at 6 months post procedure

  3. Safety: Rate of device related SAE

    Measured: at 12 months post procedure

  4. Safety: Rate of device related SAE

    Relevant only for patients 11-20

    Measured: at 24 months post procedure

  5. Effectiveness: TR Grade reduction

    Measured: post procedure (1 hour after implant device has been implanted)

  6. Effectiveness: TR Grade reduction

    Measured: Until hospital discharge - up to 5 days post procedure day

  7. Effectiveness: TR Grade reduction

    Measured: at 30 days post procedure

  8. Effectiveness: NYHA class (categorization of heart failure extent)

    Measured: at 30 days post procedure

  9. Effectiveness: 6MWT distance

    Measured: at 30 days post procedure

  10. Effectiveness: KCCQ (Kansas City Cardiomyopathy Questionnaire)

    Measured: at 30 days post procedure

  11. Effectiveness: TR Grade reduction

    Measured: at 3 months post procedure

  12. Effectiveness: NYHA class (categorization of heart failure extent)

    Measured: at 3 months post procedure

  13. Effectiveness: 6MWT distance

    Measured: at 3 months post procedure

  14. Effectiveness: KCCQ (Kansas City Cardiomyopathy Questionnaire)

    Measured: at 3 months post procedure

  15. Effectiveness: TR Grade reduction

    Measured: at 6 months post procedure

  16. Effectiveness: TR Grade reduction

    Relevant only for patients 11-20

    Measured: at 12 months post procedure

  17. Effectiveness: TR Grade reduction

    Relevant only for patients 11-20

    Measured: at 24 months post procedure

  18. Effectiveness: NYHA class (categorization of heart failure extent)

    Measured: at 6 months post procedure

  19. Effectiveness: NYHA class (categorization of heart failure extent)

    Relevant only for patients 11-20

    Measured: at 12 months post procedure

  20. Effectiveness: NYHA class (categorization of heart failure extent)

    Relevant only for patients 11-20

    Measured: at 24 months post procedure

  21. Effectiveness: 6MWT distance

    Measured: at 6 months post procedure

  22. Effectiveness: 6MWT distance

    Relevant only for patients 11-20

    Measured: at 12 months post procedure

  23. Effectiveness: 6MWT distance

    Relevant only for patients 11-20

    Measured: at 24 months post procedure

  24. Effectiveness: KCCQ (Kansas City Cardiomyopathy Questionnaire)

    Measured: at 6 months post procedure

  25. Effectiveness: KCCQ (Kansas City Cardiomyopathy Questionnaire)

    Relevant only for patients 11-20

    Measured: at 12 months post procedure

  26. Effectiveness: KCCQ (Kansas City Cardiomyopathy Questionnaire)

    Relevant only for patients 11-20

    Measured: at 24 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start8 Aug 2017
  3. Primary completion1 Oct 2020
  4. Study completion28 Feb 2023

Resources

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04071652
Sponsor's protocol ID
CL-475
Status last verified
Oct 2023
First submitted
13 Apr 2017
Last updated
19 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mistral implantation in people with Tricuspid Valve Regurgitation, run by Mitralix at 3 sites 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 23 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: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety: Acute safety. Rate of device related SAE (time frame: Until hospital discharge - up to 5 days post procedure day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071652.

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 19 Oct 2023.

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