Registry of Aortic Valve Bioprostheses Established by Catheter

Study Overview
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Brief Summary
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Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic bioprostheses through for the treatment of severe degenerative aortic stenosis Epidemiological data and the 1-year survival of aortic bioprostheses implanted by percutaneous.

Detailed Description
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Aortic valve stenosis is a serious chronic life-threatening in the short or medium term since the onset of functional symptoms. Aortic valve replacement surgery is currently the treatment of choice. It is done by surgery with sternotomy and extracorporeal circulation. However, despite the considerable improvement of the conditions of care per and post operative, this procedure is sometimes burdened with high mortality, especially in the population with severe co-morbidities and / or many. For this reason, some patients are considered against the indicated surgery or high surgical risk. The recent development of aortic valve bioprostheses implanted with new approaches (pressure or transapical) can be considered for aortic valve replacement in a population that was previously excluded. Based on very thorough evaluation of these valves test benches and animal as well as human settlements achieved through multiple studies and registries mono or multi patients challenged by cardiac surgeons or considered at high surgical risk, it is clear that the implementation of these valves could allow, under conditions of optimal implementation and monitoring, improve short-and long-term clinical status, quality of life and prognosis of patients. FRANCE 2 registry, established in 2010, and whose inclusions ended 30 June 2012 has allowed an initial assessment of aortic valve bioprostheses implanted catheter The following registry France 2 has been requested by the highest authorities of health, FRANCE register TAVI is performed in continuity FRANCE 2. It takes account of the first data FRANCE 2. Data Report Form has been reduced, no new item has been added, it will be carried out in all centers authorized in France to implement this technique. The collection of data will TAVI France under the same conditions as those FRANCE 2, the database will be managed by the French Society of Cardiology

Official Title
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Registry of Aortic Valve Bioprostheses Established by Catheter

Conditions
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Transcatheter Aortic Valve Implantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Existence of senile degenerative aortic stenosis with a transvalvular gradient by> 40 mmHg and / or maximum velocity> 4 m / sec and / or initial valve area <1 cm ² (indexed <0.6 cm ² / m²). The initial measurement of valve area must be obtained within 30 days prior to valve implantation - Presence of symptoms related to aortic stenosis (dyspnea, angina, syncope effort ...) demonstrated by Functional Classification for Congestive Heart Failure functional class> 2 or Class I, but with left ventricular dysfunction (ejection fraction <40% ) - A Score to EuroSCORE (Logistic European system for cardiac operative risk evaluation) > 20% and / or Society of Thoracic Surgeons' risk Calculator> 10. In case the EuroSCORE <20% or STS <10, confirmed that some comorbidities were not captured by these indices will be produced by the surgeon and cardiologist Some patients are in a situation against medical-cardiac surgery indicates heavy although this does not appear in the predictive risk assessment through the scores. In this regard, patients may be included in the following conditions: 3-1 - ascending aorta very calcified (porcelain) 3-2 - Any other condition preventing cannulation for cardiopulmonary bypass, aortic clamping, or access mediastinal surgery: History of 3-2-1 against mediastinal irradiation indicating open-chest 3-2-2 thoracic deformity or history of mediastinitis-cons indicating the opening of the thorax 3-2-3 Other (eg, history of coronary bypass surgery may indicate against the opening of the thorax) - The patient accepts the scheduled evaluations at follow-up clinic - The patient or his legal representatives were informed of the nature of valve implantation and associated register and accept the conditions. Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transcatheter Aortic Valve Implantation<br>FRANCE TAVI registry aims to identify all patients with a change of valves implanted catheter meets the selection criteria of the technical accepting the scheduled evaluations in the context of this disease and who have agreed to participate in the study . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year survival | After leaving the hospital, the doctor responsible for the register in each center will contact the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits. | 1 year |