Active — Not RecruitingNot Applicable

PARTNER 3 Trial - Mitral Valve in Valve

United States, Australia, Brazil53 participantsStarted 2018-02-01

Plain-language summary

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
. NYHA Functional Class ≥ II.
. Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and \< 8).
. Heart Team agrees valve implantation will likely benefit the patient.
. 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.

Exclusion criteria

. 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).
. Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
. Known residual mean gradient \>10 mmHg at the end of the index procedure for implantation of the original surgical valve.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Effectiveness - Composite of All-cause Mortality and Stroke

Timeframe: 1 Year

Trial details

NCT IDNCT03193801

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-16

Results submitted2023-08-15

View on ClinicalTrials.gov More Mitral Valve Insufficiency trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
. NYHA Functional Class ≥ II.
. Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and \< 8).
. Heart Team agrees valve implantation will likely benefit the patient.
. 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.

Exclusion criteria

. 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).
. Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
. Known residual mean gradient \>10 mmHg at the end of the index procedure for implantation of the original surgical valve.