Long-Term Effects of Aortic Valve Mismatch

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification 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 Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label	Phase 4	90	June 2009	-

Facility	Address	Contact	Phone	Email	Status
CHRU, Hôpital Civile, Service de chirurgie cardio-vasculaire	Strasbourg France	Petit -Eisenmann Bernard, MD	-	bernard.petit@chru-strasbourg.fr	Recruiting

Type	Intervention	Description
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

Type	Measure	Time Frame	Safety 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

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

Gender	Minimum Age	Maximum Age	Healthy 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.