NCT01522352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

December 20, 2011

Last Update Submit

September 2, 2013

Conditions

Aortic Valve Replacement

Keywords

Bioprosthesis,aortic valve replacementMagna EaseMitroflowTrifecta

Outcome Measures

Primary Outcomes (1)

  • measurement of postoperative trans-valvular mean gradient by echocardiography

    after 6 months

Secondary Outcomes (5)

  • Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size

    at six months

  • Comparison between the aortic annulus measurement and the implanted bioprosthesis size

    at six months

  • Surgical outcome at hospital

    at 6 months.

  • Postoperative trans-valvular mean gradient by echocardiography

    at six months.

  • Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces

    at six months.

Study Arms (1)

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)

Procedure: Aortic valve replacement by bioprosthesis

Interventions

Aortic valve replacement by bioprosthesisPROCEDURE

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)

pericardial aortic valves

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • no endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.

    PMID: 24299218DERIVED

Study Officials

  • Kasra AZARNOUSH, MD, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

January 31, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

FR(1)