Expanded Clinical Study of the Tendyne Mitral Valve System

NCT ID: NCT02321514

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2025-04-30

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.

Conditions

Mitral Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tendyne Mitral Valve System

Patients will undergo transcatheter mitral valve replacement

Group Type: EXPERIMENTAL

Tendyne Mitral Valve System

Intervention Type: DEVICE

Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

Interventions

Tendyne Mitral Valve System

Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, United States

MedStar Washington Hospital

Washington D.C., District of Columbia, United States

Morton Plan Mease Health Care

Clearwater, Florida, United States

Delray Medical Center

Delray Beach, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northshore University Health System

Evanston, Illinois, United States

Henry Ford Hospital

Detroit, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

St. Francis Hospital

Roslyn, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Pinnacle Health - Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Baylor Heart & Vascular Center

Dallas, Texas, United States

West Virginia University

Morgantown, West Virginia, United States

Flinders Medical Center

Bedford Park, , Australia

Prince Charles Hospital

Chermside, , Australia

St. Vincent's Hospital

Sydney, , Australia

Bordeaux University Hospital

Bordeaux, , France

CHRU de Lille

Lille, , France

Lyon University Hospital

Lyon, , France

Rennes University Hospital

Rennes, , France

Clinique Pasteur

Toulouse, , France

Deutsche Herzzentrum Berlin

Berlin, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

University Hospital Dresden

Dresden, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

University Heart Center Hamburg

Hamburg, , Germany

Leipzig Heart Center

Leipzig, , Germany

University Medical Center Mainz

Mainz, , Germany

Ludwig-Maximilians-Universität München (LMU)

Munich, , Germany

University of Rostock

Rostock, , Germany

Ospedale Ferrarotta - Catania

Catania, , Italy

San Raffaele

Milan, , Italy

Pisa University

Pisa, , Italy

Humanitas Research Hospital

Rozzano, , Italy

San Donato

San Donato Milanese, , Italy

St. Antonius Hospital

Nieuwegein, , Netherlands

Oslo University Hospital

Oslo, , Norway

Karolinksa University Hospital

Solna, , Sweden

University Hospital of Zurich

Zurich, , Switzerland

Royal Brompton Hospital

London, , United Kingdom

Countries

United States; Australia; France; Germany; Italy; Netherlands; Norway; Sweden; Switzerland; United Kingdom

References

Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.

Reference Type: DERIVED

PMID: 34736561 (View on PubMed)

Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28.

Reference Type: DERIVED

PMID: 28040318 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CS-03

Identifier Type: -

Identifier Source: org_study_id