Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis

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
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Malte Kelm, MD; Phone Number: 0049 211 81 18800; Email: CTSU@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • Recruiting
      • Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
      • Contact: Malte Kelm, MD; Phone Number: 0049 211 81 18800; Email: CTSU@med.uni-duesseldorf.de
      • Contact: Rabea Wagstaff, MA; Phone Number: 0049 211 81 18800; Email: ctsu@med.uni-duesseldorf.de
      • Sub-Investigator: Florian Bönner, MD
      • Sub-Investigator: Verena Veulemans, MD
      • Sub-Investigator: Kathrin Klein, MD
      • Sub-Investigator: Christian Jung, MD
      • Sub-Investigator: Oliver Maier, MD
      • Sub-Investigator: Shazia Afzal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with aortic valve stenosis screened for TAVI

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unconsciousness, not able to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Major Adverse Cardiac Event	1 month, 3 months and 12 months
Hospitalisation	1 month, 3 months and 12 months
Mortality	1 month, 3 months and 12 months
blood samples	1 month, 3 months and 12 months

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie
• Investigators: Study Director: Malte Kelm, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Publications and helpful links

General Publications

• Veulemans V, Maier O, Piayda K, Berning KL, Binnebossel S, Polzin A, Afzal S, Dannenberg L, Horn P, Jung C, Westenfeld R, Kelm M, Zeus T. Factors associated with a high or low implantation of self-expanding devices in TAVR. Clin Res Cardiol. 2021 Dec;110(12):1930-1938. doi: 10.1007/s00392-021-01901-3. Epub 2021 Jun 24.
• Piayda K, Dannenberg L, Zako S, Maier O, Bosbach G, Polzin A, Afzal S, Jung C, Westenfeld R, Kelm M, Zeus T, Veulemans V. Predictors of calcification distribution in severe tricuspid aortic valve stenosis. Int J Cardiovasc Imaging. 2021 Sep;37(9):2791-2799. doi: 10.1007/s10554-021-02248-6. Epub 2021 Apr 20.
• Veulemans V, Maier O, Bosbach G, Hellhammer K, Afzal S, Piayda K, Polzin A, Jung C, Westenfeld R, Mehdiani A, Lichtenberg A, Kelm M, Zeus T. Impact of Combined "CHADS-BLED" Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement. J Interv Cardiol. 2020 Dec 18;2020:9414397. doi: 10.1155/2020/9414397. eCollection 2020.
• Piayda K, Hellhammer K, Veulemans V, Sievert H, Gafoor S, Afzal S, Hennig I, Makosch M, Polzin A, Jung C, Westenfeld R, Kelm M, Zeus T. Navigating the "Optimal Implantation Depth" With a Self-Expandable TAVR Device in Daily Clinical Practice. JACC Cardiovasc Interv. 2020 Mar 23;13(6):679-688. doi: 10.1016/j.jcin.2019.07.048. Epub 2019 Dec 11.
• Veulemans V, Zeus T, Kleinebrecht L, Balzer J, Hellhammer K, Polzin A, Horn P, Blehm A, Minol JP, Kropil P, Westenfeld R, Rassaf T, Lichtenberg A, Kelm M. Comparison of Manual and Automated Preprocedural Segmentation Tools to Predict the Annulus Plane Angulation and C-Arm Positioning for Transcatheter Aortic Valve Replacement. PLoS One. 2016 Apr 13;11(4):e0151918. doi: 10.1371/journal.pone.0151918. eCollection 2016.
• Balzer JC, Boering YC, Mollus S, Schmidt M, Hellhammer K, Kroepil P, Westenfeld R, Zeus T, Antoch G, Linke A, Steinseifer U, Merx MW, Kelm M. Left ventricular contrast injection with rotational C-arm CT improves accuracy of aortic annulus measurement during cardiac catheterisation. EuroIntervention. 2014 Jul;10(3):347-54. doi: 10.4244/EIJV10I3A60.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 5, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: MRI; echocardiography; CT; angiography; transcatheter aortic valve implantation; rotational C-arm CT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Multi Modal Cardiac Imaging

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No