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

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

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

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