Expanded Clinical Study of the Tendyne Mitral Valve System

Completed · Not applicable

Conditions studied: Mitral Valve Regurgitation

In brief

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.

Key facts

Study ID

NCT02321514

Run by

Abbott Medical Devices

People needed

191

Starts

2014-11-01

Expected to finish

2025-04-01

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
• History of endocarditis within six months of planned implant procedure.
• Active systemic infection requiring antibiotic therapy.
• 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.
• Patient is undergoing hemodialysis due to chronic renal failure.
• Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
• Patient has COPD and is on home oxygen.
• Patient refuses blood transfusions.
• Pregnant, lactating, or planning pregnancy within next 12 months.
• Participating or planning participation in an investigational drug or another device study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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