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MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study (MERIT)

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ClinicalTrials.gov Identifier: NCT02948231
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mitralix

Brief 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. Device use is limited to the approved study investigators.


Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Mistral implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
Study Start Date : June 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Arm Intervention/treatment
Experimental: Mistral Device: Mistral implantation
Mistral Implant is implanted in the Mitral valve




Primary Outcome Measures :
  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. [ Time Frame: 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. [ Time Frame: at 30 days post-procedure ]

Secondary Outcome Measures :
  1. Safety: Rate of device related SAE [ Time Frame: at 3 months post procedure ]
  2. Safety: Rate of device related SAE [ Time Frame: at 6 months post procedure ]
  3. Safety: Rate of device related SAE [ Time Frame: at 12 months post procedure ]
  4. Effectiveness: MR Grade reduction. [ Time Frame: Post procedure (1 hour after implant device has been implanted) ]
  5. Effectiveness: MR Grade reduction. [ Time Frame: Until hospital discharge - up to 5 days post procedure day ]
  6. Effectiveness: MR Grade reduction. [ Time Frame: at 30 days post procedure ]
  7. Effectiveness: MR Grade reduction. [ Time Frame: at 3 months post procedure ]
  8. Effectiveness: MR Grade reduction. [ Time Frame: at 6 months post procedure ]
  9. Effectiveness: MR Grade reduction. [ Time Frame: at 12 months post procedure ]
  10. Effectiveness: NYHA class (categorization of heart failure extent). [ Time Frame: Post procedure (1 hour after implant device has been implanted) ]
  11. Effectiveness: NYHA class (categorization of heart failure extent) [ Time Frame: Until hospital discharge - up to 5 days post procedure day ]
  12. Effectiveness: NYHA class (categorization of heart failure extent) [ Time Frame: at 30 days post procedure ]
  13. Effectiveness: NYHA class (categorization of heart failure extent) [ Time Frame: at 3 months post procedure ]
  14. Effectiveness: NYHA class (categorization of heart failure extent) [ Time Frame: at 6 months post procedure ]
  15. Effectiveness: NYHA class (categorization of heart failure extent) [ Time Frame: at 12 months post procedure ]
  16. Effectiveness: 6MWT distance. [ Time Frame: Post procedure (1 hour after implant device has been implanted) ]
  17. Effectiveness: 6MWT distance. [ Time Frame: Until hospital discharge - up to 5 days post procedure day ]
  18. Effectiveness: 6MWT distance. [ Time Frame: at 30 days post procedure ]
  19. Effectiveness: 6MWT distance. [ Time Frame: at 3 months post procedure ]
  20. Effectiveness: 6MWT distance. [ Time Frame: at 6 months post procedure ]
  21. Effectiveness: 6MWT distance. [ Time Frame: at 12 months post procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948231


Contacts
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Contact: Ira Yaron +972544402636 ira@mitralix.com

Locations
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Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Contact: Inge Joris       inge.joris@zna.be   
Sponsors and Collaborators
Mitralix
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Responsible Party: Mitralix
ClinicalTrials.gov Identifier: NCT02948231    
Other Study ID Numbers: CL-133
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases