Registry of Aortic Valve Bioprostheses Established by Catheter
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- - 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% )
- - The patient accepts the scheduled evaluations at follow-up clinic
- - 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% )
- - The patient accepts the scheduled evaluations at follow-up clinic
- - 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
- - The patient or his legal representatives were informed of the nature of valve implantation and associated register and accept the conditions.
Exclusion Criteria
- none
- none
Summary
- Conditions
- Transcatheter Aortic Valve Implantation
- Design
- Observational Model: Cohort
- Time Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 considerab...
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
Inclusion Criteria
- - 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% )
- - The patient accepts the scheduled evaluations at follow-up clinic
- - 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% )
- - The patient accepts the scheduled evaluations at follow-up clinic
- - 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
- - The patient or his legal representatives were informed of the nature of valve implantation and associated register and accept the conditions.
Exclusion Criteria
- none
- none
Tracking Information
- NCT #
- NCT01777828
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hervé Le Breton AP
- Hervé Le Breton AP
Get Well Soon