We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

This study is currently recruiting participants.
Verified November 2017 by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Sponsor:
ClinicalTrials.gov Identifier:
NCT01805739
First Posted: March 6, 2013
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Philips Healthcare
TomTec Imaging Systems GmbH
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
March 1, 2013
March 6, 2013
November 28, 2017
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 ]
Same as current
Complete list of historical versions of study NCT01805739 on ClinicalTrials.gov Archive Site
  • left ventricular contrast injection [ Time Frame: baseline ]
  • Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT). [ Time Frame: baseline ]
Same as current
  • Major Adverse Cardiac Event [ Time Frame: 1 month, 3 months and 12 months ]
  • Hospitalisation [ Time Frame: 1 month, 3 months and 12 months ]
  • Mortality [ Time Frame: 1 month, 3 months and 12 months ]
  • blood samples [ Time Frame: 1 month, 3 months and 12 months ]
  • Major Adverse Cardiac Event [ Time Frame: 1 month, 3 months and 12 months ]
  • Hospitalisation [ Time Frame: 1 month, 3 months and 12 months ]
  • Mortality [ Time Frame: 1 month, 3 months and 12 months ]
 
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
Time Perspective: Other
12 Months
Not Provided
Non-Probability Sample
patients with aortic valve stenosis screened for TAVI
Aortic Valve Stenosis
Not Provided
Not Provided
 
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Malte Kelm, MD 0049 211 81 18800 CTSU@med.uni-duesseldorf.de
Germany
 
 
NCT01805739
Multi Modal Cardiac Imaging
No
Not Provided
Not Provided
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
November 2017