NCT01805739 Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation
| NCT ID | NCT01805739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klinik für Kardiologie, Pneumologie und Angiologie |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2013-01 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2013-01 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * aortic valve stenosis * screened for TAVI * written informed consent Exclusion Criteria: * unconsciousness, not able to consent
Contact & Investigator
Malte Kelm, MD
STUDY DIRECTOR
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Frequently Asked Questions
Who can join the NCT01805739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01805739 currently recruiting?
Yes, NCT01805739 is actively recruiting participants. Contact the research team at CTSU@med.uni-duesseldorf.de for enrollment information.
Where is the NCT01805739 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT01805739 clinical trial?
NCT01805739 is sponsored by Klinik für Kardiologie, Pneumologie und Angiologie. The principal investigator is Malte Kelm, MD at Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf. The trial plans to enroll 5,000 participants.