Active Not Recruiting NA INTERVENTIONAL 1-arm NCT01757665

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) (COMMENCE)

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

Sponsor: Edwards Lifesciences

Conditions Aortic Stenosis Aortic Valve Insufficiency Heart Failure Mitral Stenosis Mitral Valve Insufficiency

Interventions Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Updated 20 times since 2017 Last updated: Nov 11, 2025 Started: Dec 11, 2012 Primary completion: Aug 31, 2017 Completion: Aug 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Aortic Stenosis and Aortic Valve Insufficiency, this trial is ongoing. The trial is conducted by Edwards Lifesciences and has accumulated 20 data snapshots since 2012. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

Change History

20 versions recorded

Dec 2025 — Present [monthly]

Active Not Recruiting NA
Sep 2025 — Dec 2025 [monthly]

Active Not Recruiting NA
Feb 2025 — Sep 2025 [monthly]

Active Not Recruiting NA
Sep 2024 — Feb 2025 [monthly]

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Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting NA

▶ Show 15 earlier versions

Feb 2024 — Jul 2024 [monthly]

Active Not Recruiting NA
Feb 2023 — Feb 2024 [monthly]

Active Not Recruiting NA
Feb 2022 — Feb 2023 [monthly]

Active Not Recruiting NA
Feb 2021 — Feb 2022 [monthly]

Active Not Recruiting NA
Jan 2021 — Feb 2021 [monthly]

Active Not Recruiting NA
Mar 2020 — Jan 2021 [monthly]

Active Not Recruiting NA
Feb 2020 — Mar 2020 [monthly]

Active Not Recruiting NA
Jan 2020 — Feb 2020 [monthly]

Active Not Recruiting NA
Sep 2019 — Jan 2020 [monthly]

Active Not Recruiting NA
Oct 2018 — Sep 2019 [monthly]

Active Not Recruiting NA
Aug 2018 — Oct 2018 [monthly]

Active Not Recruiting NA
Jun 2018 — Aug 2018 [monthly]

Active Not Recruiting NA
Sep 2017 — Jun 2018 [monthly]

Active Not Recruiting NA
Feb 2017 — Sep 2017 [monthly]

Active Not Recruiting NA
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting NA

First recorded

Dec 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Edwards Lifesciences

Data source: Edwards Lifesciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Baltimore, United States , Birmingham, United States , Cleveland, United States , Columbus, United States , Gainesville, United States , Grand Rapids, United States , Houston, United States , Indianapolis, United States , Kansas City, United States and 16 more locations