Ignite Creation Date:
2024-05-06 @ 2:39 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04385459
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2020-05-06
Brief Title:
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Sponsor:
Örebro County Council
Organization:
Örebro County Council
Study Overview
Official Title:
Long Term Follow-up 5 Years for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2021-09
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:
None
Brief Summary:
Patients undergoing surgical aortic valve replacement sAVR with concomitant coronary artery disease CAD are known to have higher mortality rates compared to patients without CAD This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure
Detailed Description:
A narrowing of the aortic valve aortic stenosis is a relatively common condition among the elderly When the narrowing gets too severe symptoms such as loss of breath angina and fainting can occur so called symptomatic aortic stenosis Since the 60s surgical aortic valve replacement sAVR has been the treatment of choice for severe aortic stenosis A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk
Transcatheter aortic valve implantation TAVI have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade The procedure which is a minimal invasive type of surgery introduces a new aortic valve through a catheter usually transfemorally Patients with an underlying coronary artery disease CAD undergoing sAVR is known to have higher mortality rates postoperatively However it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI
Transcatheter aortic valve implantation TAVI have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade The procedure which is a minimal invasive type of surgery introduces a new aortic valve through a catheter usually transfemorally Patients with an underlying coronary artery disease CAD undergoing sAVR is known to have higher mortality rates postoperatively However it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI
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