Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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 4, 2014
Last verified: March 2014
  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.


Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

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

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805739

Contacts
Contact: Malte Kelm, MD 0049 211 81 18800 Kardiologie@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    Kardiologie@med.uni-duesseldorf.de   
Principal Investigator: Malte Kelm, MD         
Sub-Investigator: Jan Balzer, MD         
Sub-Investigator: Florian Bönner, MD         
Sub-Investigator: Yang-Chul Böring, MD         
Sub-Investigator: Sebastian Grünig, MD         
Sub-Investigator: Katharina Hellhammer, MD         
Sub-Investigator: Ulrike Ketterer, MD         
Sub-Investigator: Marc W. Merx, MD         
Sub-Investigator: Mirja Neizel-Wittke, MD         
Sub-Investigator: Burkhard Sievers, MD         
Sub-Investigator: Tobias Zeus, 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:
No publications provided

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
Study First Received: March 1, 2013
Last Updated: March 4, 2014
Health Authority: Germany: Ethic Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014