---
title: Comparison Between Three Types of Stented Pericardial Aortic Valves
nct_id: NCT01522352
overall_status: UNKNOWN
phase: NA
sponsor: University Hospital, Clermont-Ferrand
study_type: INTERVENTIONAL
primary_condition: Aortic Valve Replacement
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01522352.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01522352"
ct_last_update_post_date: 2013-09-04
last_seen_at: "2026-05-12T06:42:47.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison Between Three Types of Stented Pericardial Aortic Valves

**Official Title:** Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves

**NCT ID:** [NCT01522352](https://clinicaltrials.gov/study/NCT01522352)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 165
- **Lead Sponsor:** University Hospital, Clermont-Ferrand
- **Collaborators:** Edwards Lifesciences, Abbott Medical Devices, Sorin group, Italy, Ministry of Health, France
- **Conditions:** Aortic Valve Replacement
- **Start Date:** 2012-03
- **Completion Date:** 2013-12
- **CT.gov Last Update:** 2013-09-04

## Brief Summary

This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

## Detailed Description

According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.

Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.

Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery

Exclusion Criteria:

* no endocarditis
```

## Arms

- **pericardial aortic valves** (EXPERIMENTAL) — Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)

## Interventions

- **Aortic valve replacement by bioprosthesis** (PROCEDURE) — Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)

## Primary Outcomes

- **measurement of postoperative trans-valvular mean gradient by echocardiography** _(time frame: after 6 months)_

## Secondary Outcomes

- **Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size** _(time frame: at six months)_
- **Comparison between the aortic annulus measurement and the implanted bioprosthesis size** _(time frame: at six months)_
- **Surgical outcome at hospital** _(time frame: at 6 months.)_
- **Postoperative trans-valvular mean gradient by echocardiography** _(time frame: at six months.)_
- **Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces** _(time frame: at six months.)_

## Locations (1)

- CHU Clermont-Ferrand, Clermont-Ferrand, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu clermont-ferrand|clermont-ferrand||france` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01522352.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01522352*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*