Expanded Clinical Study of the Tendyne Mitral Valve System

NCT02321514 | Completed Results DMC FDA Device

• 1 other identifier: CS-03
• Study Type: interventional
• Target: 191
• Locations: 10 countries
• Sites: 40

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

Keywords

ABT-CIP-10337; Tendyne Bioprosthetic Mitral Valve System

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)

  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

  30 days post-index procedure

• Performance Endpoint: Number of Participants With MR Grade ≤ 2

  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.

  30 days post-index procedure

Study Arms (1)

Tendyne Mitral Valve System

EXPERIMENTAL

Patients will undergo transcatheter mitral valve replacement

Device: Tendyne Mitral Valve System

Interventions

Tendyne Mitral Valve System DEVICE

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

Tendyne Mitral Valve System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• New York Heart Association (NYHA) functional Class ≥ II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.
• Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.
• Age 18 years or older.

You may not qualify if:

• Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
• Left Ventricle (LV) or Left Atrium (LA) thrombus.
• Patient has a chest condition that prevents transapical access.
• Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
• Left Ventricular End Diastolic Diameter (LVEDD) \> 7.0 cm.
• 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.).
• 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.
• Cardiac resynchronization therapy device or implantable pulse generator implanted within three months of planned implant procedure.
• Myocardial Infarction (MI) within 30 days of the planned implant procedure.
• Symptomatic, unresolved multi-vessel coronary artery disease (CAD) or unprotected left main coronary artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
• Cerebrovascular accident (CVA) within six months of planned implant procedure.
• Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound).
• Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
• Severe tricuspid regurgitation, tricuspid valve disease requiring surgery or severe right ventricular dysfunction.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (40)

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

Location

MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plan Mease Health Care

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Pinnacle Health - Harrisburg Hospital

Harrisburg, Pennsylvania, 17104, United States

Location

Baylor Heart & Vascular Center

Dallas, Texas, 75226, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Flinders Medical Center

Bedford Park, 5042, Australia

Location

Prince Charles Hospital

Chermside, Australia

Location

St. Vincent's Hospital

Sydney, Australia

Location

Bordeaux University Hospital

Bordeaux, France

Location

CHRU de Lille

Lille, 59000, France

Location

Lyon University Hospital

Lyon, France

Location

Rennes University Hospital

Rennes, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Deutsche Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

University Hospital Dresden

Dresden, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

University Heart Center Hamburg

Hamburg, 20251, Germany

Location

Leipzig Heart Center

Leipzig, 04289, Germany

Location

University Medical Center Mainz

Mainz, 55131, Germany

Location

Ludwig-Maximilians-Universität München (LMU)

Munich, Germany

Location

University of Rostock

Rostock, 18057, Germany

Location

Ospedale Ferrarotta - Catania

Catania, 95124, Italy

Location

San Raffaele

Milan, 20132, Italy

Location

Pisa University

Pisa, Italy

Location

Humanitas Research Hospital

Rozzano, 56-20089, Italy

Location

San Donato

San Donato Milanese, 20097, Italy

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Karolinksa University Hospital

Solna, 17176, Sweden

Location

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34736561 DERIVED

• 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.

  PMID: 28040318 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Karine Miquel, PhD
• Organization: Abbott

karine.miquel@abbott.com

+32 479 600 107

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 22, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: April 1, 2025
• Last Updated: July 17, 2025
• Results First Posted: September 2, 2021

Record last verified: 2025-07

Locations

DE (9); IT (5); US (13); NL (1); SE (1); CH (1); FR (5); GB (1); NO (1); AU (3)