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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02321514




Registration number
NCT02321514
Ethics application status
Date submitted
10/12/2014
Date registered
22/12/2014
Date last updated
8/05/2024

Titles & IDs
Public title
Expanded Clinical Study of the Tendyne Mitral Valve System
Scientific title
Expanded Clinical Study of the Tendyne Mitral Valve System
Secondary ID [1] 0 0
CS-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Tendyne Mitral Valve System

Experimental: Tendyne Mitral Valve System - Patients will undergo transcatheter mitral valve replacement


Treatment: Devices: Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
Timepoint [1] 0 0
30 days post-index procedure
Primary outcome [2] 0 0
Performance Endpoint: Number of Participants With MR Grade = 2
Timepoint [2] 0 0
30 days post-index procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [2] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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West Virginia
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France
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Bordeaux
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France
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Lille
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France
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Lyon
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France
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Rennes
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Munich
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Italy
State/province [23] 0 0
Catania
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Italy
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Milan
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Italy
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Pisa
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Italy
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Rozzano
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Italy
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San Donato Milanese
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Netherlands
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Nieuwegein
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Norway
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Oslo
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Sweden
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Solna
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Switzerland
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Zürich
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United Kingdom
State/province [32] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02321514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02321514