CompletedNot Applicable

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

United States, Austria, Canada283 participantsStarted 2007-10

Plain-language summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Who can participate

Age range

18 Years

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

. The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
. The patient is an average or better operative risk.
. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
. The patient is 18 years or older.
. The patient has signed and dated the subject informed consent form prior to surgery.

Exclusion criteria

. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.

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

Subject's Percentage of Long Term Safety Performance

Timeframe: 31 days through 8 years post-implant

Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant

Timeframe: 8 years post-implant

Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline

Timeframe: 8 Years post-implant

Trial details

NCT IDNCT01171625

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2020-02-06

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