Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Heinrich-Heine University, Duesseldorf
Sponsor:
Collaborators:
Philips Healthcare
TomTec Imaging Systems GmbH
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01805739
First received: March 1, 2013
Last updated: March 18, 2015
Last verified: March 2015

March 1, 2013
March 18, 2015
January 2013
December 2020   (final data collection date for primary outcome measure)
Assessment of diameters of the aortic annulus using the different imaging modalities [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01805739 on ClinicalTrials.gov Archive Site
  • left ventricular contrast injection [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT). [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
Same as current
  • Major Adverse Cardiac Event [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Hospitalisation [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • blood samples [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Hospitalisation [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 1 month, 3 months and 12 months ] [ Designated as safety issue: Yes ]
 
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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
12 Months
Not Provided
Non-Probability Sample

patients with aortic valve stenosis screened for TAVI

Aortic Valve Stenosis
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • unconsciousness, not able to consent
Both
18 Years and older
No
Contact: Malte Kelm, MD 0049 211 81 18800 Kardiologie@med.uni-duesseldorf.de
Germany
 
NCT01805739
Multi Modal Cardiac Imaging
No
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Klinik für Kardiologie, Pneumologie und Angiologie
  • Philips Healthcare
  • TomTec Imaging Systems GmbH
Study Director: Malte Kelm, MD Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Heinrich-Heine University, Duesseldorf
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP