Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation
NCT ID: NCT01805739
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2013-01-31
2030-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* screened for TAVI
* written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Klinik für Kardiologie, Pneumologie und Angiologie
OTHER
Responsible Party
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Klinik für Kardiologie, Pneumologie und Angiologie
Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine
Principal Investigators
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Malte Kelm, MD
Role: STUDY_DIRECTOR
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Locations
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Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Veulemans V, Heermann J, Adrichem R, Hecht S, Seppelt PC, Hokken TW, Nuis RJ, Abdel-Wahab M, van Mieghem NM, Leistner D, Vorpahl MM, Zeus T. Evidence of bioprosthetic valve dysfunction during three-year follow-up following TAVR. Clin Res Cardiol. 2025 May 12. doi: 10.1007/s00392-025-02630-7. Online ahead of print.
Quast C, Bonner F, Polzin A, Veulemans V, Chennupati R, Gyamfi Poku I, Pfeiler S, Kramser N, Nankinova M, Staub N, Zweck E, Jokiel J, Keyser F, Hoffe J, Witkowski S, Becker K, Leuders P, Zako S, Erkens R, Jung C, Flogel U, Wang T, Neidlin M, Steinseifer U, Niepmann ST, Zimmer S, Gerdes N, Cortese-Krott MM, Feelisch M, Zeus T, Kelm M. Aortic Valve Stenosis Causes Accumulation of Extracellular Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.
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.
Other Identifiers
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Multi Modal Cardiac Imaging
Identifier Type: -
Identifier Source: org_study_id