NCT01805739

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2013Dec 2030

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
17.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

17.9 years

First QC Date

March 1, 2013

Last Update Submit

October 28, 2020

Conditions

Aortic Valve Stenosis

Keywords

transcatheter aortic valve implantationCTMRIangiographyechocardiographyrotational C-arm CT

Outcome Measures

Primary Outcomes (2)

  • Assessment of diameters of the aortic annulus using the different imaging modalities

    baseline

  • Implantation depth (ID) measured from NCC in fluoroscopic view

    baseline

Secondary Outcomes (5)

  • 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 Outcomes (4)

  • 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

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with aortic valve stenosis screened for TAVI

You may qualify if:

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

You may not qualify if:

  • unconsciousness, not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Related Publications (8)

  • 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.

    PMID: 40353875DERIVED

  • 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.

    PMID: 38836358DERIVED

  • 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.

    PMID: 34165599DERIVED

  • 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.

    PMID: 33877483DERIVED

  • 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.

    PMID: 33380924DERIVED

  • 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.

    PMID: 31838114DERIVED

  • 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.

    PMID: 27073910DERIVED

  • 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.

    PMID: 24755302DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

    STUDY DIRECTOR

Central Study Contacts

Malte Kelm, MD

CONTACT

0049 211 81 18800CTSU@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 6, 2013

Study Start

January 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

DE(1)