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Completed Not applicable Interventional Results available

Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

ClinicalTrials.gov ID: NCT00853632

Public ClinicalTrials.gov record NCT00853632. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00853632
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
329 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2007 (Type not available)
Primary completion
Mar 6, 2024 (Actual)
Completion
Mar 6, 2024 (Actual)
Last update posted
May 14, 2025

2007 – 2024

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Dignity Health Research Institute Sacramento California 95816 —
AdventHealth Orlando Orlando Florida 32803 —
Northwestern University Hospital Chicago Illinois 60611 —
University of Iowa Hospital & Clinics Iowa City Iowa 52242 —
Iowa Heart Medical Center West Des Moines Iowa 50266 —
University of Michigan Medical School Ann Arbor Michigan 48109 —
Spectrum Health Hospitals Grand Rapids Michigan 49503 —
Missouri Baptist Medical Center St Louis Missouri 63131 —
North Shore University Hospital, NY Manhasset New York 11030 —
Long Island Jewish Medical Center New Hyde Park New York 11040 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00853632, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 14, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00853632 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →