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

Primary Purpose

Mitral Valve Regurgitation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mistral implantation
Sponsored by
Mitralix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ZNA Middelheim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mistral

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Safety: Rate of device related SAE
Safety: Rate of device related SAE
Safety: Rate of device related SAE
Effectiveness: MR Grade reduction.
Effectiveness: MR Grade reduction.
Effectiveness: MR Grade reduction.
Effectiveness: MR Grade reduction.
Effectiveness: MR Grade reduction.
Effectiveness: MR Grade reduction.
Effectiveness: NYHA class (categorization of heart failure extent).
Effectiveness: NYHA class (categorization of heart failure extent)
Effectiveness: NYHA class (categorization of heart failure extent)
Effectiveness: NYHA class (categorization of heart failure extent)
Effectiveness: NYHA class (categorization of heart failure extent)
Effectiveness: NYHA class (categorization of heart failure extent)
Effectiveness: 6MWT distance.
Effectiveness: 6MWT distance.
Effectiveness: 6MWT distance.
Effectiveness: 6MWT distance.
Effectiveness: 6MWT distance.
Effectiveness: 6MWT distance.

Full Information

First Posted
June 21, 2016
Last Updated
April 6, 2022
Sponsor
Mitralix
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1. Study Identification

Unique Protocol Identification Number
NCT02948231
Brief Title
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
Acronym
MERIT
Official Title
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2016 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitralix

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mistral
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mistral implantation
Intervention Description
Mistral Implant is implanted in the Mitral valve
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
Safety: Rate of device related SAE
Time Frame
at 3 months post procedure
Title
Safety: Rate of device related SAE
Time Frame
at 6 months post procedure
Title
Safety: Rate of device related SAE
Time Frame
at 12 months post procedure
Title
Effectiveness: MR Grade reduction.
Time Frame
Post procedure (1 hour after implant device has been implanted)
Title
Effectiveness: MR Grade reduction.
Time Frame
Until hospital discharge - up to 5 days post procedure day
Title
Effectiveness: MR Grade reduction.
Time Frame
at 30 days post procedure
Title
Effectiveness: MR Grade reduction.
Time Frame
at 3 months post procedure
Title
Effectiveness: MR Grade reduction.
Time Frame
at 6 months post procedure
Title
Effectiveness: MR Grade reduction.
Time Frame
at 12 months post procedure
Title
Effectiveness: NYHA class (categorization of heart failure extent).
Time Frame
Post procedure (1 hour after implant device has been implanted)
Title
Effectiveness: NYHA class (categorization of heart failure extent)
Time Frame
Until hospital discharge - up to 5 days post procedure day
Title
Effectiveness: NYHA class (categorization of heart failure extent)
Time Frame
at 30 days post procedure
Title
Effectiveness: NYHA class (categorization of heart failure extent)
Time Frame
at 3 months post procedure
Title
Effectiveness: NYHA class (categorization of heart failure extent)
Time Frame
at 6 months post procedure
Title
Effectiveness: NYHA class (categorization of heart failure extent)
Time Frame
at 12 months post procedure
Title
Effectiveness: 6MWT distance.
Time Frame
Post procedure (1 hour after implant device has been implanted)
Title
Effectiveness: 6MWT distance.
Time Frame
Until hospital discharge - up to 5 days post procedure day
Title
Effectiveness: 6MWT distance.
Time Frame
at 30 days post procedure
Title
Effectiveness: 6MWT distance.
Time Frame
at 3 months post procedure
Title
Effectiveness: 6MWT distance.
Time Frame
at 6 months post procedure
Title
Effectiveness: 6MWT distance.
Time Frame
at 12 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium

12. IPD Sharing Statement

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MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

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