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

> **NCT01757665** · NA · COMPLETED · sponsor: **Edwards Lifesciences** · enrollment: 777 (actual)

## Conditions studied

- Aortic Stenosis
- Mitral Stenosis
- Aortic Valve Insufficiency
- Mitral Valve Insufficiency
- Heart Failure

## Interventions

- **DEVICE:** Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

## Key facts

- **NCT ID:** NCT01757665
- **Lead sponsor:** Edwards Lifesciences
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-12-11
- **Primary completion:** 2017-08
- **Final completion:** 2026-03-23
- **Target enrollment:** 777 (ACTUAL)
- **Last updated:** 2026-05-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01757665

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01757665, "ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)". Retrieved via AI Analytics 2026-07-12 from https://api.ai-analytics.org/clinical/NCT01757665. Licensed CC0.

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