Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477042
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-18
Brief Title:
Act on Quality of Life in Patients With aortIc Stenosis
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPINIST
Brief Summary:
Aortic stenosis AS is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions The prognosis is poorly with survival rates of only 15-50 at 5 years AS has a major impact on quality of life with severely limiting symptoms dyspnea chest pain often leading to repeated hospitalizations It is the most common valvular disease in Europe and North America and its prevalence is increasing as the population ages In Europe 17 of the population is aged 65 or over in France this proportion will reach 30 by 2030 corresponding to 16 million people The incidence of aortic valve sclerosis early stage AS is around 25 at age 65 rising to 48 after age 75 The prevalence of aortic valve disease is likely to continue to rise given the expected evolution of the age pyramid
There is no medical treatment able to slow down the degenerative process of the valve and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention Aortic valve replacement has historically been performed surgically with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis Now Transcatheter Aortic Valve Implantation TAVI has replaced this procedure This involves inserting a bioprosthesis crimped into a stent via an endovascular route ie without opening the thorax Deployment of the stent crushes the native valve leaving the functional bioprosthesis in place
Initially developed for patients contraindicated to surgery TAVI is now offered as a first-line treatment for patients aged 75 and over
Inexistent before 2010 the number of TAVIs equalled the number of surgeries by 2015 and TAVIs currently account for ¾ of aortic valve procedures unpublished data
There is no medical treatment able to slow down the degenerative process of the valve and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention Aortic valve replacement has historically been performed surgically with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis Now Transcatheter Aortic Valve Implantation TAVI has replaced this procedure This involves inserting a bioprosthesis crimped into a stent via an endovascular route ie without opening the thorax Deployment of the stent crushes the native valve leaving the functional bioprosthesis in place
Initially developed for patients contraindicated to surgery TAVI is now offered as a first-line treatment for patients aged 75 and over
Inexistent before 2010 the number of TAVIs equalled the number of surgeries by 2015 and TAVIs currently account for ¾ of aortic valve procedures unpublished data
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None