Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01805739
• Other study ID #: Multi Modal Cardiac Imaging
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2030

Study information

• Verified date: October 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Malte Kelm, MD
• Phone: 0049 211 81 18800
• Email: CTSU[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aortic valve stenosis

• screened for TAVI

• written informed consent

Exclusion Criteria:

• unconsciousness, not able to consent

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Adverse Cardiac Event		1 month, 3 months and 12 months
Other	Hospitalisation		1 month, 3 months and 12 months
Other	Mortality		1 month, 3 months and 12 months
Other	blood samples		1 month, 3 months and 12 months
Primary	Assessment of diameters of the aortic annulus using the different imaging modalities		baseline
Primary	Implantation depth (ID) measured from NCC in fluoroscopic view		baseline
Secondary	left ventricular contrast injection		baseline
Secondary	Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).		baseline
Secondary	mean pressure gradient		baseline
Secondary	paravalvular aortic regurgitation		baseline
Secondary	bleeding and vascular access site complications		baseline