CompletedNot Applicable

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

United States283 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 range18 Years

SexALL

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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.
✕. The patient presents with active endocarditis within the last 3 months.
✕. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
✕. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
✕. The patient is pregnant or lactating.
✕. The patient is an intravenous drug abuser.
✕. The patient is currently a prison inmate.
✕. The patient is currently participating in a study of an investigational drug or device.

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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