Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Location status: Recruiting
NCT Number: NCT01805739
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline
Time frame: baseline
Time frame: baseline
Time frame: baseline
Time frame: baseline
Time frame: baseline
Time frame: baseline
Time frame: 1 month, 3 months and 12 months
Time frame: 1 month, 3 months and 12 months
Time frame: 1 month, 3 months and 12 months
Time frame: 1 month, 3 months and 12 months
Interested in participating?
Request InfoKlinik für Kardiologie, Pneumologie und Angiologie
Other
Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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