Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01805739
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• aortic valve stenosis
• screened for TAVI
• written informed consent

Exclusion Criteria

• unconsciousness, not able to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implantation depth (ID) measured from NCC in fluoroscopic view	baseline
Assessment of diameters of the aortic annulus using the different imaging modalities	baseline

Secondary Outcome Measures

Name	Time	Method
mean pressure gradient	baseline
left ventricular contrast injection	baseline
Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).	baseline
bleeding and vascular access site complications	baseline
paravalvular aortic regurgitation	baseline

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, NRW, Germany