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
5000
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