Clinical trial NCT02321514: Expanded Clinical Study of the Tendyne Mitral Valve System
Official title: Expanded Clinical Study of the Tendyne Mitral Valve System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: ABT-CIP-10337
Tendyne Bioprosthetic Mitral Valve System
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
timeFrame: 30 days post-index procedure
measure: Performance Endpoint: Number of Participants With MR Grade ≤ 2
timeFrame: 30 days post-index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Scottsdale Shea Medical Center
state: Arizona
city: Washington
country: United States
facility: MedStar Washington Hospital
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Harrisburg
country: United States
facility: Pinnacle Health - Harrisburg Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Heart & Vascular Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Bedford Park
country: Australia
facility: Flinders Medical Center
city: Chermside
country: Australia
facility: Prince Charles Hospital
city: Sydney
country: Australia
facility: St. Vincent's Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Lyon University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
city: Berlin
country: Germany
facility: Deutsche Herzzentrum Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Leipzig
country: Germany
facility: Leipzig Heart Center
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität München (LMU)
city: Catania
country: Italy
facility: Ospedale Ferrarotta - Catania
city: Milan
country: Italy
facility: San Raffaele
city: Pisa
country: Italy
facility: Pisa University
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
city: San Donato Milanese
country: Italy
facility: San Donato
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Solna
country: Sweden
facility: Karolinksa University Hospital
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
citation: 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.
citation: 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.