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SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464876
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
InnovHeart

Brief Summary:
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Valve Heart Disease Heart Valve Diseases Mitral Valve Disease Mitral Disease Device: SATURN TA System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Treatment
SATURN TA TMVR Device implanted
Device: SATURN TA System
SATURN TA TMVR Device implanted




Primary Outcome Measures :
  1. Freedom from device-related or procedure-related major adverse events [ Time Frame: 30 days ]
    Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).

  2. Reduction of mitral regurgitation [ Time Frame: 30 days ]
    Reduction of mitral regurgitation to ≤1 at 30 days.

  3. Technical success [ Time Frame: Day 0 ]

    Technical success defined as alive patient at exit from procedure room, with all of the following:

    • Successful access, delivery and retrieval of the delivery systems.
    • Development and correct positioning of the bioprosthesis.
    • Freedom of additional emergency surgery or re-intervention related to the device or access procedure.


Secondary Outcome Measures :
  1. Freedom from device-related or procedure-related major adverse events [ Time Frame: 30 days, 1 year, 2 years ]
    • Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.
    • Freedom from all-cause mortality

  2. Freedom from all-cause mortality [ Time Frame: 30 days, 1 year, 2 years ]
    Freedom from all-cause mortality

  3. Patients success [ Time Frame: 30 days, 1 year, 2 years ]
    Patients success

  4. Device success [ Time Frame: 30 days, 1 year, 2 years ]
    Device success

  5. 6 Minute Hall Walk Test [ Time Frame: 30 days, 1 year, 2 years ]
    Improvement from baseline in functional status by ≥ 30 meters

  6. KCCQ [ Time Frame: 30 days, 1 year, 2 years ]
    Improvement from baseline in Quality of Life by ≥ 10 points.

  7. NYHA functional classification [ Time Frame: 30 days, 1 year, 2 years ]
    Improvement from baseline by ≥ 1 functional classification.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Age 18 years or older.
  2. Severe functional mitral regurgitation (≥ Grade 3+).
  3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
  4. Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
  5. Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
  6. Able to complete quality-of-life assessment (KCCQ).

General Exclusion Criteria:

  1. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
  2. Life expectancy <1 yr due to noncardiac conditions.
  3. Active endocarditis.
  4. Active systemic infection.
  5. Modified Rankin Scale ≥4 disability.
  6. Hemodialysis/ chronic renal failure (eGFR < 35 mL/min/m2).
  7. Pulmonary arterial hypertension (fixed PAS < 60mmHg). 8) COPD on home oxygen.

9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).

11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.

12) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.

13) Participating in other investigational studies likely to confound the results or affect the study.

14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".

Cardiovascular Exclusion Criteria:

  1. Myocardial infarction during prior 30 days.
  2. Stroke or TIA during prior 30 days.
  3. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
  4. Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
  5. Prior surgical mechanical valve AVR.
  6. Prior TAVI.
  7. Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days.
  8. CRT or ICD implanted in previous 30 days.
  9. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
  10. CABG or PCI within previous 30 days.
  11. Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization.
  12. Prior or planned heart transplantation (UNOS status 1).
  13. Physical evidence of right-sided congestive heart failure:

    1. Patients with ascites.
    2. Patients with anasarca (generalized edema / hydropsy).

    Procedural Exclusion Criteria:

  14. Chest condition that prevents transapical access.
  15. Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
  16. Documented hypersensitivity to nickel or titanium.

Cardiac Exclusion Criteria (evaluated by Core Labs):

  1. Left ventricular EF ≤ 30% by imaging.
  2. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
  3. Extensive mitral flail leaflets.
  4. Left ventricular thrombus, mass, or vegetation.
  5. Left ventricular end-diastolic diameter > 7.5 cm.
  6. Severe right ventricular dysfunction.
  7. Significant intracardiac shunt.
  8. Anatomic ineligibility for SATURN valve as determined by the Screening Committee.

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): NCT04464876


Contacts
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Contact: Carrie Vooght 603-560-9067 c.vooght@innovheart.com

Locations
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Lithuania
Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania
Contact: Eglė Rumbinaitė, MD         
Principal Investigator: Rimantas Benetis, MD, PhD         
Vilnius University Hospital Santaros klinikos Recruiting
Vilnius, Lithuania
Contact: Andrej Podkopajev, MD         
Principal Investigator: Kęstutis Ručinskas, MD, PhD         
Sponsors and Collaborators
InnovHeart
Investigators
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Study Director: Carrie Vooght InnovHeart
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Responsible Party: InnovHeart
ClinicalTrials.gov Identifier: NCT04464876    
Other Study ID Numbers: TP-0050
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Cardiovascular Diseases