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NCT Number: NCT01805739

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location status: Recruiting

Location contact

Christian Jung, MD

SUB_INVESTIGATOR

Florian Bönner, MD

SUB_INVESTIGATOR

Katharina Hellhammer, MD

SUB_INVESTIGATOR

Kathrin Klein, MD

SUB_INVESTIGATOR

Malte Kelm, MD

CONTACT

[email protected]

0049 211 81 18800

Malte Kelm, MD

PRINCIPAL_INVESTIGATOR

Oliver Maier, MD

SUB_INVESTIGATOR

Rabea Wagstaff, MA

CONTACT

[email protected]

0049 211 81 18800

Ralf Westenfeld, MD

SUB_INVESTIGATOR

Shazia Afzal, MD

SUB_INVESTIGATOR

Tobias Zeus, MD

SUB_INVESTIGATOR

Verena Veulemans, MD

SUB_INVESTIGATOR

About this study

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.

Substudy: "Real-World Experience with Implantation Depth Optimization according to 2020 Recommendations for Evolut R Self-Expanding Transcatheter Aortic Valve: the Düsseldorf Best Practice Trial." Aortic valve stenosis treated by transcatheter aortic valve replacement (TAVR) is one of the most fast-growing sections in interventional cardiology. The Heart Center Düsseldorf is a high-volume center for treatment of patients suffering of aortic stenosis treated by TAVR, so we have a great interest in further investigation of process optimizing and improvement. Therefore, we will focus on optimization of implantation depth (ID) according to Medtronic®'s best practice recommendations for TAVR deployment in July 2020 regarding new-generation devices Medtronic® CoreValve Evolut. Optimal ID is an important condition for hemodynamic and clinical outcome due to increased risk of paravalvular leakage or even valve embolization in implantation that is located too high, whereas deep implantation is associated with more aortic regurgitation an increased risk of conduction disturbances associated with higher rates of permanent pacemaker implantation. The aim of this single-center observational study is to investigate short-term clinical performance, safety and efficiency outcomes in patients undergoing transfemoral TAVR regarding Medtronic®'s best practice advices of July 2020 for TAVR deployment with CoreValve Evolut.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unconsciousness, not able to consent

Treatment and study plan

Primary outcomes

  1. Assessment of diameters of the aortic annulus using the different imaging modalities

    Time frame: baseline

  2. Implantation depth (ID) measured from NCC in fluoroscopic view

    Time frame: baseline

Secondary outcomes

  1. left ventricular contrast injection

    Time frame: baseline

  2. Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).

    Time frame: baseline

  3. mean pressure gradient

    Time frame: baseline

  4. paravalvular aortic regurgitation

    Time frame: baseline

  5. bleeding and vascular access site complications

    Time frame: baseline

Other outcomes

  1. Major Adverse Cardiac Event

    Time frame: 1 month, 3 months and 12 months

  2. Hospitalisation

    Time frame: 1 month, 3 months and 12 months

  3. Mortality

    Time frame: 1 month, 3 months and 12 months

  4. blood samples

    Time frame: 1 month, 3 months and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Malte Kelm, MD

CONTACT

[email protected]

0049 211 81 18800

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Mar 6, 2013
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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