Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

Brief Title

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

Official Title

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)

Brief Summary

      Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic
      stenosis for patients ineligible for open heart surgery or at high risk for perioperative
      complications. Pre-procedural imaging of the aortic root is essential for selection of the
      correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly
      subsequent embolization, coronary obstruction, annulus rupture or severe aortic
      regurgitation.

      The aim of the study is to compare the different imaging modalities for aortic root
      measurements.

      Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be
      performed either into the aorta or into the left ventricle. The datasets will be assessed by
      blinded-independent observers in a multi-planar reconstruction view.

      The study will be performed retrospectively (2009-2012) and prospectively starting 2013.

Detailed Description

      Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic
      stenosis for patients ineligible for open heart surgery or at high risk for perioperative
      complications. Pre-procedural imaging of the aortic root is essential for selection of the
      correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly
      subsequent embolization, coronary obstruction, annulus rupture or severe aortic
      regurgitation.

      The aim of the study is to compare the different imaging modalities for aortic root
      measurements.

      Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be
      performed either into the aorta or into the left ventricle. The datasets will be assessed by
      blinded-independent observers in a multi-planar reconstruction view.

      The study will be performed retrospectively (2009-2012) and prospectively starting 2013.

      Substudy: "Real-World Experience with Implantation Depth Optimization according to 2020
      Recommendations for Evolut R Self-Expanding Transcatheter Aortic Valve: the Düsseldorf Best
      Practice Trial." Aortic valve stenosis treated by transcatheter aortic valve replacement
      (TAVR) is one of the most fast-growing sections in interventional cardiology. The Heart
      Center Düsseldorf is a high-volume center for treatment of patients suffering of aortic
      stenosis treated by TAVR, so we have a great interest in further investigation of process
      optimizing and improvement. Therefore, we will focus on optimization of implantation depth
      (ID) according to Medtronic®'s best practice recommendations for TAVR deployment in July 2020
      regarding new-generation devices Medtronic® CoreValve Evolut. Optimal ID is an important
      condition for hemodynamic and clinical outcome due to increased risk of paravalvular leakage
      or even valve embolization in implantation that is located too high, whereas deep
      implantation is associated with more aortic regurgitation an increased risk of conduction
      disturbances associated with higher rates of permanent pacemaker implantation. The aim of
      this single-center observational study is to investigate short-term clinical performance,
      safety and efficiency outcomes in patients undergoing transfemoral TAVR regarding
      Medtronic®'s best practice advices of July 2020 for TAVR deployment with CoreValve Evolut.

Study Type

Observational [Patient Registry]

Primary Outcome

Assessment of diameters of the aortic annulus using the different imaging modalities

Secondary Outcome

 left ventricular contrast injection

Condition

Aortic Valve Stenosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

January 2013

Completion Date

December 2030

Primary Completion Date

December 2030

Eligibility Criteria

        Inclusion Criteria:

          -  aortic valve stenosis

          -  screened for TAVI

          -  written informed consent

        Exclusion Criteria:

          -  unconsciousness, not able to consent

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Malte Kelm, MD, 0049 211 81 18800, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT01805739

Organization ID

Multi Modal Cardiac Imaging

Responsible Party

Sponsor-Investigator

Study Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Study Sponsor

Malte Kelm, MD, Study Director, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Verification Date

October 2020