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Mitral Valve RegurgitationMERITNCT02948231

MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

A study testing Mistral implantation in people with Mitral Valve Regurgitation, run by Mitralix at 1 site in Belgium.

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 Mitral Regurgitation. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral 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
4 participants
Where
1 siteBelgium
Study dates
25 Jun 2016to Feb 2022
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 is willing and able to comply with all required follow-up evaluations
  • Genders eligible for the study: Both genders
  • Subject has functional MR of grade 3+ or more
  • Subject has left ventricular ejection fraction (LVEF) >20 % and < 40%.
  • No contraindications to trans-septal puncture
  • Subject is of functional class 3 or more (NYHA)
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  • The subject is high risk to undergo MV surgery.
  • Subject is excluded from other standard of care procedures as determined by center heart team.
  • Patients with femoral veins enabling catheterization with 12Fr catheters
  • Life expectancy ≥ 1 year

Who cannot join

  • Mitral Stenosis ≥ moderate
  • Aortic Stenosis/Insufficiency > moderate
  • Subvalvular calcification or calcification of the chordae.
  • Subject has a prosthesis valve in the mitral position
  • Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration
  • Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
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  • Subject has a history of a myocardial infarction (MI) in the past 3 months
  • Subject refuses blood transfusion or surgical valve replacement.
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • ZNA Middelheim

    Antwerp, 2020

Other trials in Belgium

About this study

The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.

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 (Primary Endpoint) 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 (3 and 6 months follow up).
  • Demonstrate effectiveness of the Mistral device in improving MR.

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.

Secondary endpoints:

  • • Safety: Safety at 3 and 6 months. Rate of SAEs and device related SAEs at 3, 6 and 12months.
  • Effectiveness: MR reduction post-procedure, at discharge and 30 days, 3 and 6 and 12 months. Improved NYHA class and 6MWT distance at 30 days, 3 and 6 and 12 months.
Being tested
Mistral implantation
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.

  • Mistral implantationDevice

    Mistral Implant is implanted in the Mitral valve

Study groups in NCT02948231
Study groupRoleWhat they receive
MistralExperimentalNot described
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

Secondary outcomes (21)

  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. Effectiveness: MR Grade reduction.

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

  5. Effectiveness: MR Grade reduction.

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

  6. Effectiveness: MR Grade reduction.

    Measured: at 30 days post procedure

  7. Effectiveness: MR Grade reduction.

    Measured: at 3 months post procedure

  8. Effectiveness: MR Grade reduction.

    Measured: at 6 months post procedure

  9. Effectiveness: MR Grade reduction.

    Measured: at 12 months post procedure

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

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

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

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

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

    Measured: at 30 days post procedure

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

    Measured: at 3 months post procedure

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

    Measured: at 6 months post procedure

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

    Measured: at 12 months post procedure

  16. Effectiveness: 6MWT distance.

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

  17. Effectiveness: 6MWT distance.

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

  18. Effectiveness: 6MWT distance.

    Measured: at 30 days post procedure

  19. Effectiveness: 6MWT distance.

    Measured: at 3 months post procedure

  20. Effectiveness: 6MWT distance.

    Measured: at 6 months post procedure

  21. Effectiveness: 6MWT distance.

    Measured: at 12 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 Oct 2016 (estimated)
  2. Study start25 Jun 2016
  3. Primary completionJan 2021
  4. Study completionFeb 2022

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02948231
Sponsor's protocol ID
CL-133
Acronym
MERIT
Status last verified
Feb 2022
First submitted
21 Jun 2016
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Mistral implantation in people with Mitral Valve Regurgitation, run by Mitralix at 1 site in Belgium.

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 25 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 7 Apr 2022. 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 Belgium. 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 including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event. (time frame: Until hospital discharge - up to 5 days post procedure day). 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?

On the ClinicalTrials.gov record for NCT02948231.

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 7 Apr 2022.

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