Trial Review

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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/NCT03193801




Registration number
NCT03193801
Ethics application status
Date submitted
19/06/2017
Date registered
21/06/2017
Date last updated
24/10/2023

Titles & IDs
Public title
PARTNER 3 Trial - Mitral Valve in Valve
Scientific title
PARTNER 3 Trial - 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 of All-cause Mortality and Stroke
Timepoint [1] 0 0
1 Year
Secondary outcome [1] 0 0
New York Heart Association (NYHA) Functional Class - Change From Baseline
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Mitral Regurgitation - Change From Baseline
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Pulmonary Artery Systolic Pressure - Change From Baseline
Timepoint [4] 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. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to
28.5 mm.

3. NYHA Functional Class = II.

4. Heart Team agrees the patient is intermediate risk (i.e. STS score of =3 and < 8).

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

6. 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) / Ethics Committee (EC) of the respective clinical site.
Minimum age
No limit
Maximum age
No limit
Sex
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. Surgical or transcatheter aortic valve placed so that extension into left ventricular
outflow tract (LVOT) that may impinge on the mitral implant.

3. Known residual mean gradient >10 mmHg at the end of the index procedure for
implantation of the original surgical valve.

4. Severe right ventricle (RV) dysfunction.

5. Anatomical characteristics that would preclude safe access to the apex (transapical).

6. Severe regurgitation or stenosis of any other valve.

7. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen

8. Severe pulmonary hypertension (e.g., PA systolic pressure = 2/3 systemic pressure)

9. Anatomical characteristics that would increase risk of LVOT obstruction (e.g.,
aortomitral angle, LVOT size, etc.).

10. Evidence of an acute myocardial infarction = 1 month (30 days) before enrollment.

11. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days prior to the index procedure. Implantation of a permanent
pacemaker (PPM) or implantable cardioverter defibrillator (ICD) is not considered an
exclusion.

12. Patients with planned concomitant surgical or transcatheter ablation for atrial
fibrillation.

13. Leukopenia (white blood count < 3000 cell/mL), anemia (hemoglobin < 9 g/dL),
thrombocytopenia (blood platelet count < 50,000 cell/mL), history of bleeding
diathesis or coagulopathy, or hypercoagulable states.

14. Untreated clinically significant coronary artery disease requiring revascularization.

15. Hemodynamic or respiratory instability requiring inotropic support, mechanical
ventilation, or mechanical heart assistance within 30 days of enrollment.

16. Emergency intervention/surgical procedures within one month (30 days) prior to the
procedure.

17. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed
within the 30-day follow-up from the procedure.

18. Hypertrophic cardiomyopathy with obstruction (HOCM).

19. Left ventricular ejection fraction (LVEF) < 30%.

20. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.

21. Inability to tolerate or condition precluding treatment with
antithrombotic/anticoagulation therapy during or after the valve implant procedure.

22. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
treated with premedication.

23. Stroke or transient ischemic attack (TIA) within 90 days of enrollment.

24. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within 30 days of enrollment.

25. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal
replacement therapy at the time of screening.

26. Active bacterial endocarditis within 6 months (180 days) of the procedure.

27. Patient refuses blood products.

28. Estimated life expectancy < 24 months.

29. Currently participating in an investigational drug or another device study. Note:
Clinical trials requiring extended follow-up for products that were investigational,
but have since become commercially available, are not considered investigational
trials.

30. Positive urine or serum pregnancy test in female subjects of childbearing potential.

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
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2031
Actual
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
4032 - Chermside
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
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo

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 transcatheter heart valve in patients
with a failing mitral bioprosthetic valve.
Trial website
https://clinicaltrials.gov/ct2/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
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/NCT03193801