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
  Purpose

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.


Condition
Aortic Valve Stenosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)

Resource links provided by NLM:


Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Assessment of diameters of the aortic annulus using the different imaging modalities [ Time Frame: baseline ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with aortic valve stenosis screened for TAVI
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unconsciousness, not able to consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805739


Contacts
Contact: Malte Kelm, MD 0049 211 81 18800 CTSU@med.uni-duesseldorf.de

Locations
Germany
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Malte Kelm, MD    0049 211 81 18800    CTSU@med.uni-duesseldorf.de   
Principal Investigator: Malte Kelm, MD         
Sub-Investigator: Florian Bönner, MD         
Sub-Investigator: Katharina Hellhammer, MD         
Sub-Investigator: Mirja Neizel-Wittke, MD         
Sub-Investigator: Tobias Zeus, MD         
Sub-Investigator: Ralf Westenfeld, MD         
Sub-Investigator: Verena Veulemans, MD         
Sub-Investigator: Laura Kleinebrecht, MD         
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Philips Healthcare
TomTec Imaging Systems GmbH
Investigators
Study Director: Malte Kelm, MD Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01805739     History of Changes
Other Study ID Numbers: Multi Modal Cardiac Imaging
First Submitted: March 1, 2013
First Posted: March 6, 2013
Last Update Posted: November 28, 2017
Last Verified: November 2017

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
transcatheter aortic valve implantation
CT
MRI
angiography
echocardiography
rotational C-arm CT

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction