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Expanded Clinical Study of the Tendyne Mitral Valve System

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02321514
Recruitment Status : Active, not recruiting
First Posted : December 22, 2014
Results First Posted : September 2, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Tendyne Mitral Valve System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Clinical Study of the Tendyne Mitral Valve System
Actual Study Start Date : November 2014
Actual Primary Completion Date : July 2020
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement
 Device: Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system


Outcome Measures
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Primary Outcome Measures :
  1. Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs) [ Time Frame: 30 days post-index procedure ]

    Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC):

    • Cardiovascular death
    • Reintervention caused by valve-related dysfunction
    • Disabling stroke
    • Myocardial infarction (MI)
    • Life-threatening bleeding (BARC Type 2, 3, and 5)
    • Major Vascular Complications
    • Renal failure requiring dialysis
    • Other device-related SAEs
    • Other procedure-related SAEs

  2. Performance Endpoint: Number of Participants With MR Grade ≤ 2 [ Time Frame: 30 days post-index procedure ]

    Proportion of subjects with mitral regurgitation (MR) grade ≤ 2, per echocardiography core laboratory will be assessed.

    MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.



Eligibility Criteria
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Information from the National Library of Medicine

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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. Severe mitral regurgitation of primary or secondary etiology according to MVARC (Mitral Valve Academic Research Consortium) 2015 defined as:

    • For Degenerative MR: EROA ≥ 40 mm^2 or regurgitant volume ≥ 60ml
    • For Secondary MR: EROA ≥ 20 mm^2 or regurgitant volume ≥ 30ml
  2. New York Heart Association (NYHA) functional Class ≥ II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.
  3. Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.
  4. Age 18 years or older.

Exclusion Criteria:

  1. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
  2. Left Ventricle (LV) or Left Atrium (LA) thrombus.
  3. Patient has a chest condition that prevents transapical access.
  4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
  5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
  6. Prior surgical or interventional treatment of mitral or aortic valves (e.g. valve repair or replacement, MitraClip, edge to edge repair, aortic balloon valvuloplasty, etc.).
  7. Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
  8. Cardiac resynchronization therapy device or implantable pulse generator implanted within three months of planned implant procedure.
  9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.
  10. Symptomatic, unresolved multi-vessel coronary artery disease (CAD) or unprotected left main coronary artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
  11. Cerebrovascular accident (CVA) within six months of planned implant procedure.
  12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  13. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  14. Severe tricuspid regurgitation, tricuspid valve disease requiring surgery or severe right ventricular dysfunction.
  15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
  16. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
  17. History of endocarditis within six months of planned implant procedure.
  18. Active systemic infection requiring antibiotic therapy.
  19. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically or hypersensitivity to nickel or titanium.
  20. Patient is undergoing hemodialysis due to chronic renal failure.
  21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
  22. Patient has COPD and is on home oxygen.
  23. Patient refuses blood transfusions.
  24. Pregnant, lactating, or planning pregnancy within next 12 months.
  25. Participating or planning participation in an investigational drug or another device study.
  26. Patient or legal guardian unable or unwilling to give informed consent.
  27. Patient unable or unwilling to comply with study required testing and follow-up visits.
  28. Patients with non-cardiac co-morbidities that are likely to result in a life expectancy of less than one year.
Contacts and Locations
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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): NCT02321514


Locations
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Sponsors and Collaborators
Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] February 20, 2020
Statistical Analysis Plan  [PDF] April 27, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02321514    
Other Study ID Numbers: CS-03
First Posted: December 22, 2014    Key Record Dates
Results First Posted: September 2, 2021
Last Update Posted: January 6, 2022
Last Verified: January 2022
Keywords provided by Abbott Medical Devices:
ABT-CIP-10337
Tendyne Bioprosthetic Mitral Valve System
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases