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Clinical Trials/NCT04385459
NCT04385459
Completed
Not Applicable

Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease

Örebro County Council1 site in 1 country346 target enrollmentDecember 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
Örebro County Council
Enrollment
346
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2018
End Date
December 24, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Örebro County Council
Responsible Party
Principal Investigator
Principal Investigator

Ninos Samano M.D.

MD, PhD

Örebro County Council

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.

Outcomes

Primary Outcomes

Mortality

Time Frame: Five years.

Death after the procedure

Secondary Outcomes

  • Factors associated with less favorable early and late mortality(Five years)

Study Sites (1)

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