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Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01805739
Enrollment
5000
Registered
2013-03-06
Start date
2013-01-31
Completion date
2030-12-31
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

transcatheter aortic valve implantation, CT, MRI, angiography, echocardiography, rotational C-arm CT

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.

Interventions

None listed

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* unconsciousness, not able to consent

Design outcomes

Primary

MeasureTime frame
Assessment of diameters of the aortic annulus using the different imaging modalitiesbaseline
Implantation depth (ID) measured from NCC in fluoroscopic viewbaseline

Secondary

MeasureTime frame
Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).baseline
left ventricular contrast injectionbaseline
mean pressure gradientbaseline
paravalvular aortic regurgitationbaseline
bleeding and vascular access site complicationsbaseline

Other

MeasureTime frame
blood samples1 month, 3 months and 12 months
Mortality1 month, 3 months and 12 months
Major Adverse Cardiac Event1 month, 3 months and 12 months
Hospitalisation1 month, 3 months and 12 months

Countries

Germany

Contacts

Primary ContactMalte Kelm, MD
CTSU@med.uni-duesseldorf.de0049 211 81 18800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026