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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02321514
Ethics application status
Date submitted
10/12/2014
Date registered
22/12/2014
Date last updated
7/07/2020

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 - Transcatheter mitral valve replacement


Treatment: Devices: Tendyne Mitral Valve System
Transcatheter mitral valve replacement

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety assessed by freedom from device or procedure related adverse events
Timepoint [1] 0 0
30-days
Primary outcome [2] 0 0
Performance assessed by freedom from device malfunction
Timepoint [2] 0 0
30-days

Eligibility
Key inclusion criteria
1. Severe mitral regurgitation of primary or secondary etiology

2. NYHA functional Class = II. If IV, patient must be ambulatory

3. Heart team determines patient is not a suitable candidate for traditional surgical
treatment

4. Age 18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe mitral calcification or mitral stenosis

2. Chest condition that prevents transapical access

3. Prior surgical or interventional treatment of mitral or aortic valves

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [2] 0 0
District of Columbia
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Georgia
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United States of America
State/province [5] 0 0
Illinois
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United States of America
State/province [6] 0 0
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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Ohio
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United States of America
State/province [9] 0 0
Pennsylvania
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United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Rennes
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
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Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Germany
State/province [23] 0 0
Mainz
Country [24] 0 0
Germany
State/province [24] 0 0
Munich
Country [25] 0 0
Germany
State/province [25] 0 0
Rostock
Country [26] 0 0
Italy
State/province [26] 0 0
Catania
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Pisa
Country [29] 0 0
Italy
State/province [29] 0 0
Rozzano
Country [30] 0 0
Italy
State/province [30] 0 0
San Donato Milanese
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nieuwegein
Country [32] 0 0
Norway
State/province [32] 0 0
Oslo
Country [33] 0 0
Sweden
State/province [33] 0 0
Solna
Country [34] 0 0
Switzerland
State/province [34] 0 0
Zürich
Country [35] 0 0
United Kingdom
State/province [35] 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 generate initial insights into the safety and performance of
the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral
regurgitation who are not suitable candidates for conventional mitral valve repair or
replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up
evaluations will be conducted through 5 years post implantation.
Trial website
https://clinicaltrials.gov/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
Other publications