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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03193801




Registration number
NCT03193801
Ethics application status
Date submitted
19/06/2017
Date registered
21/06/2017
Date last updated
5/02/2020

Titles & IDs
Public title
PARTNER 3 Trial - Mitral Valve in Valve
Scientific title
PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Secondary ID [1] 0 0
2015-08 MVIV
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Experimental: Failing mitral transcatheter valve - Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.


Treatment: Devices: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.

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

Outcomes
Primary outcome [1] 0 0
Safety and Effectiveness - composite endpoint of all-cause mortality and stroke - Non-hierarchical composite endpoint of all-cause mortality and stroke at 1 year post procedure.
Timepoint [1] 0 0
1 Year
Secondary outcome [1] 0 0
New York Heart Association (NYHA) Functional Class - NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Timepoint [1] 0 0
30 Days

Eligibility
Key inclusion criteria
1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating
= moderate stenosis and/or = moderate insufficiency.

2. NYHA Functional Class = II.

3. Heart Team agrees that the patient is at intermediate surgical risk.

4. Heart Team agrees valve implantation will likely benefit the patient.

5. The study patient has been informed of the nature of the study, agrees to its
provisions and has provided written informed consent as approved by the Institutional
Review Board (IRB) of the respective clinical site.
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Index valve has = mild paravalvular regurgitation where the surgical bioprosthesis is
not securely fixed in the native annulus or is not structurally intact as determined
by transesophageal echocardiography (TEE).

2. Aortomitral angle <105°.

3. Severe regurgitation or stenosis of any other valve.

4. Severe right ventricle (RV) dysfunction.

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
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)
QLD,SA
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,
California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Trial website
https://clinicaltrials.gov/show/NCT03193801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mayra Guerrero, MD
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharanjeet Dhanjal
Address 0 0
Country 0 0
Phone 0 0
949-250-2083
Fax 0 0
Email 0 0
Sharanjeet_Dhanjal@edwards.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03193801