Brief Title
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
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
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 60's, 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.
Study Type
Observational
Primary Outcome
Mortality
Secondary Outcome
Factors associated with less favorable early and late mortality
Condition
Aortic Valve Stenosis
Intervention
Coronary artery disease
Study Arms / Comparison Groups
Patients without coronary artery disease
Description: No prior coronary intervention and no significant stenosis noted during coronary angiography.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
346
Start Date
December 13, 2018
Completion Date
December 24, 2020
Primary Completion Date
December 24, 2020
Eligibility Criteria
Inclusion Criteria:
- All patients that underwent a TAVI procedure at Örebro University Hospital between
2009 till 1st december 2019.
Exclusion Criteria:
- Patients with procedural-related coronary artery injury and patients with solitary
stenosis in a diagonal branch were excluded from the study.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Ninos Samano, MD,PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT04385459
Organization ID
273468
Responsible Party
Principal Investigator
Study Sponsor
Örebro County Council
Study Sponsor
Ninos Samano, MD,PhD, Principal Investigator, Department of Cardiothoracic and Vascular Surgery, Örebro University
Verification Date
May 2020