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Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification

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: NCT03539458
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Tendyne Holdings, Inc.

Brief Summary:
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification. Subjects satisfying the study criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Insufficiency Mitral Annular Calcification Mitral Annulus Calcification Cardiovascular Diseases Valve Heart Disease Heart Valve Diseases Heart Valve Calcification Device: Tendyne Mitral Valve System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: Device Arm
All subjects will undergo procedure with the Tendyne Mitral Valve System.
Device: Tendyne Mitral Valve System
Mitral valve replacement




Primary Outcome Measures :
  1. Procedural Success [ Time Frame: 30 days ]

    Defined as:

    Device Success and freedom from device and procedure related serious adverse events per MVARC criteria



Secondary Outcome Measures :
  1. Technical Success [ Time Frame: Intraoperative ]
    Technical Success per MVARC criteria

  2. Patient Success [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Patient Success per MVARC criteria

  3. Device Success [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Device Success per MVARC criteria

  4. Freedom from all-cause mortality [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
  5. 6 Minute Walk Test (6MWT) [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Improvement from baseline in functional status by >= 50 meters

  6. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Improvement from baseline in Quality of Life by >= 10 points

  7. New York Heart Association (NYHA) functional classification [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Improvement from baseline by >= 1 functional classification



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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. Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of Mitral Annular Calcification (MAC) present and, the subject will likely benefit from transcatheter valve implantation
  2. Severe, symptomatic mitral regurgitation (as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR)
  3. New York Heart Association (NYHA) Functional Classification ≥ II (if Class IV, patient must be ambulatory)
  4. Age 18 years or older at time of consent
  5. Not a member of a vulnerable population per the investigator's judgment
  6. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent

Exclusion Criteria:

  1. Presence of Left Ventricle or Left Atrium thrombus
  2. Subject has a chest condition that prevents transapical access
  3. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
  4. Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm
  5. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
  6. Prior intervention with permanently implanted mitral device (e.g. MitraClip)
  7. Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation
  8. Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure
  9. Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure
  10. Myocardial Infarction (MI) within 30 days prior to the planned implant procedure
  11. Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or Coronary Artery Bypass Grafting (CABG)
  12. Cerebrovascular accident (CVA) within six months prior to the planned implant procedure
  13. Unresolved severe symptomatic carotid stenosis (>70% by ultrasound)
  14. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure
  15. Severe tricuspid regurgitation or severe right ventricular dysfunction
  16. 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
  17. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated
  18. History of endocarditis within 6 months of planned implant procedure
  19. Active systemic infection requiring antibiotic therapy
  20. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically
  21. Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation
  22. Known hypersensitivity to nickel or titanium
  23. Subject is undergoing hemodialysis due to chronic renal failure ( > Stage 4 Chronic Kidney Disease (CKD))
  24. Subject has pulmonary arterial hypertension (fixed PAS >70mmHg) Note: If PAS > 70mmHg, site must provide documentation PAS is not fixed in order to be eligible
  25. Forced Expiratory Volume during the first second (FEV1) < 50% of predicted or < 1L
  26. Subject refuses blood transfusions
  27. Subject has Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
  28. Pregnant, lactating, or planning pregnancy within next 12 months Note: Female subjects of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release)
  29. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
  30. Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months

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): NCT03539458


Contacts
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Contact: David Pomfret +1 (651) 289-5500 david.pomfret@abbott.com
Contact: Shaveta Walia +1 (651) 233-7609 shaveta.walia@abbott.com

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kieth Moyer       Keith.T.Moyer@medstar.net   
Principal Investigator: Vinod Thourani, M.D.         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Charles       Elizabeth.z.charles@emroy.edu   
Principal Investigator: Vasilis Babaliaros         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Contact: Elizabeth Persels       elizabeth.persels@cckheart.com   
Principal Investigator: Bassem Chehab, M.D.         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Karlee Gebhart       Karlee.Gebhart@allina.com   
Principal Investigator: Paul Sorajja, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Annina Guzek       annina.guzek@wvumedicine.org   
Principal Investigator: Vinay Bhadwar         
Sponsors and Collaborators
Tendyne Holdings, Inc.

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Responsible Party: Tendyne Holdings, Inc.
ClinicalTrials.gov Identifier: NCT03539458     History of Changes
Other Study ID Numbers: CS0005-P
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Calcinosis
Cardiovascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases