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Long-Term Effects of Aortic Valve Mismatch


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT University Hospital, Strasbourg, France Other March 2, 2009 June 29, 2012 June 2012

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label Phase 4 90 June 2009 -

Locations

FacilityAddressContactPhoneEmailStatus
CHRU, Hôpital Civile, Service de chirurgie cardio-vasculaire Strasbourg France Petit -Eisenmann Bernard, MD - bernard.petit@chru-strasbourg.fr Recruiting

Intervention

TypeInterventionDescription
Other exercice training subjects are asked to exercice 20 or 30 minutes.
Other subjects are asked to exercice during 20 or 30 minutes subjects are asked to exercice during 20 or 30 minutes

Outcome

TypeMeasureTime FrameSafety Issue
Primary variations in VO2 max during an effort 1 year No
Secondary Study the impact of a MVA after RVA by mechanical prosthesis 1 year No

Official Title

Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - 60 Years No

Inclusion Criteria:

- Patient major ≤ 60 years at the time of the aortic valve replacement.

- Patient affiliated with a social security

- Consent dated and signed by the investigator and the subject

- Subject having been informed of the results of the visit prior aortic valve
replacement by mechanical prosthesis for pure aortic narrowing.

- Fraction left ventricular ejection ≥ 50%, when aortic valve replacement and at the
time of inclusion.

- Aortic insufficiency at aortic valve replacement associated

- aortic valve replacement exclusive (no gestures associated: coronary bypass,
enlargement of the ring, another valve surgery,…).

- Coronarographie normal at the aortic valve replacement.

- Normal renal function.

- No history of heart failure episode in the previous month inclusion.

- No indication against a stress test on bicycle ergometric

Exclusion Criteria:

- Refusal of the patient to be included in the study.

- History of cardiac surgery under extra body movement before and / or after the aortic
valve replacement.

- Aortic insufficiency associated with the time of the transaction> II / IV.

- Chronic respiratory insufficiency.

- Track cancer or cancer evolving.

- Evolutionary Osteoarthritis of the lower limbs or widespread.

- Myopathy device.

- Alteration higher making it impossible to carry out the test effort and response to
the questionnaire on the quality of life.

- Coronaropathie documented.