Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385459
• Other study ID #: 273468
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: December 24, 2020

Study information

• Verified date: September 2021
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Coronary artery disease
Exposure

Locations

Country	Name	City	State
Sweden	Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death after the procedure	Five years.
Secondary	Factors associated with less favorable early and late mortality	Factors such as renal function or comorbidities associated with higher mortality.	Five years