Aortic Valve StenosisNCT01805739
Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with aortic valve stenosis screened for TAVI
Who may be able to join
- aortic valve stenosis
- screened for TAVI
- written informed consent
Who cannot join
- unconsciousness, not able to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Malte Kelm, MD, 0049 211 81 18800, CTSU@med.uni-duesseldorf.de
Rabea Wagstaff, MA, 0049 211 81 18800, ctsu@med.uni-duesseldorf.de
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis
- Keywords
- transcatheter aortic valve implantation, CT, MRI, angiography, echocardiography, rotational C-arm CT
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of diameters of the aortic annulus using the different imaging modalities
Measured: baseline
Implantation depth (ID) measured from NCC in fluoroscopic view
Measured: baseline
Secondary outcomes (5)
left ventricular contrast injection
Measured: baseline
Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).
Measured: baseline
mean pressure gradient
Measured: baseline
paravalvular aortic regurgitation
Measured: baseline
bleeding and vascular access site complications
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, MD, Study director, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805739
- Sponsor's protocol ID
- Multi Modal Cardiac Imaging
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2013
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Veulemans V, Heermann J, Adrichem R, Hecht S, Seppelt PC, Hokken TW, Nuis RJ, Abdel-Wahab M, van Mieghem NM, Leistner D, Vorpahl MM, Zeus T. Evidence of bioprosthetic valve dysfunction during three-year follow-up following TAVR. Clin Res Cardiol. 2026 Jul;115(7):1087-1098. doi: 10.1007/s00392-025-02630-7. Epub 2025 May 12.
PubMed 40353875Quast C, Bonner F, Polzin A, Veulemans V, Chennupati R, Gyamfi Poku I, Pfeiler S, Kramser N, Nankinova M, Staub N, Zweck E, Jokiel J, Keyser F, Hoffe J, Witkowski S, Becker K, Leuders P, Zako S, Erkens R, Jung C, Flogel U, Wang T, Neidlin M, Steinseifer U, Niepmann ST, Zimmer S, Gerdes N, Cortese-Krott MM, Feelisch M, Zeus T, Kelm M. Aortic Valve Stenosis Causes Accumulation of Extracellular Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.
PubMed 38836358Veulemans V, Maier O, Piayda K, Berning KL, Binnebossel S, Polzin A, Afzal S, Dannenberg L, Horn P, Jung C, Westenfeld R, Kelm M, Zeus T. Factors associated with a high or low implantation of self-expanding devices in TAVR. Clin Res Cardiol. 2021 Dec;110(12):1930-1938. doi: 10.1007/s00392-021-01901-3. Epub 2021 Jun 24.
PubMed 34165599Piayda K, Dannenberg L, Zako S, Maier O, Bosbach G, Polzin A, Afzal S, Jung C, Westenfeld R, Kelm M, Zeus T, Veulemans V. Predictors of calcification distribution in severe tricuspid aortic valve stenosis. Int J Cardiovasc Imaging. 2021 Sep;37(9):2791-2799. doi: 10.1007/s10554-021-02248-6. Epub 2021 Apr 20.
PubMed 33877483Veulemans V, Maier O, Bosbach G, Hellhammer K, Afzal S, Piayda K, Polzin A, Jung C, Westenfeld R, Mehdiani A, Lichtenberg A, Kelm M, Zeus T. Impact of Combined "CHADS-BLED" Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement. J Interv Cardiol. 2020 Dec 18;2020:9414397. doi: 10.1155/2020/9414397. eCollection 2020.
PubMed 33380924Piayda K, Hellhammer K, Veulemans V, Sievert H, Gafoor S, Afzal S, Hennig I, Makosch M, Polzin A, Jung C, Westenfeld R, Kelm M, Zeus T. Navigating the "Optimal Implantation Depth" With a Self-Expandable TAVR Device in Daily Clinical Practice. JACC Cardiovasc Interv. 2020 Mar 23;13(6):679-688. doi: 10.1016/j.jcin.2019.07.048. Epub 2019 Dec 11.
PubMed 31838114Veulemans V, Zeus T, Kleinebrecht L, Balzer J, Hellhammer K, Polzin A, Horn P, Blehm A, Minol JP, Kropil P, Westenfeld R, Rassaf T, Lichtenberg A, Kelm M. Comparison of Manual and Automated Preprocedural Segmentation Tools to Predict the Annulus Plane Angulation and C-Arm Positioning for Transcatheter Aortic Valve Replacement. PLoS One. 2016 Apr 13;11(4):e0151918. doi: 10.1371/journal.pone.0151918. eCollection 2016.
PubMed 27073910Balzer JC, Boering YC, Mollus S, Schmidt M, Hellhammer K, Kroepil P, Westenfeld R, Zeus T, Antoch G, Linke A, Steinseifer U, Merx MW, Kelm M. Left ventricular contrast injection with rotational C-arm CT improves accuracy of aortic annulus measurement during cardiac catheterisation. EuroIntervention. 2014 Jul;10(3):347-54. doi: 10.4244/EIJV10I3A60.
PubMed 24755302
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT01805739
- Acronym / sponsor ID
- Multi Modal Cardiac Imaging
- Conditions
- Aortic Valve Stenosis
- Keywords
- transcatheter aortic valve implantation, CT, MRI, angiography, echocardiography, rotational C-arm CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with aortic valve stenosis screened for TAVI
Key inclusion criteria (3 listed)
- aortic valve stenosis
- screened for TAVI
- written informed consent
Key exclusion criteria (1 listed)
- unconsciousness, not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of diameters of the aortic annulus using the different imaging modalities
Time frame: baseline
Implantation depth (ID) measured from NCC in fluoroscopic view
Time frame: baseline
5 secondary outcomes
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
mean pressure gradient
Time frame: baseline
paravalvular aortic regurgitation
Time frame: baseline
bleeding and vascular access site complications
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 40353875Veulemans V, Heermann J, Adrichem R, Hecht S, Seppelt PC, Hokken TW, Nuis RJ, Abdel-Wahab M, van Mieghem NM, Leistner D, Vorpahl MM, Zeus T. Evidence of bioprosthetic valve dysfunction during three-year follow-up following TAVR. Clin Res Cardiol. 2026 Jul;115(7):1087-1098. doi: 10.1007/s00392-025-02630-7. Epub 2025 May 12.
- Derived from this study: PubMed 38836358Quast C, Bonner F, Polzin A, Veulemans V, Chennupati R, Gyamfi Poku I, Pfeiler S, Kramser N, Nankinova M, Staub N, Zweck E, Jokiel J, Keyser F, Hoffe J, Witkowski S, Becker K, Leuders P, Zako S, Erkens R, Jung C, Flogel U, Wang T, Neidlin M, Steinseifer U, Niepmann ST, Zimmer S, Gerdes N, Cortese-Krott MM, Feelisch M, Zeus T, Kelm M. Aortic Valve Stenosis Causes Accumulation of Extracellular Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.
- Derived from this study: PubMed 34165599Veulemans V, Maier O, Piayda K, Berning KL, Binnebossel S, Polzin A, Afzal S, Dannenberg L, Horn P, Jung C, Westenfeld R, Kelm M, Zeus T. Factors associated with a high or low implantation of self-expanding devices in TAVR. Clin Res Cardiol. 2021 Dec;110(12):1930-1938. doi: 10.1007/s00392-021-01901-3. Epub 2021 Jun 24.
- Derived from this study: PubMed 33877483Piayda K, Dannenberg L, Zako S, Maier O, Bosbach G, Polzin A, Afzal S, Jung C, Westenfeld R, Kelm M, Zeus T, Veulemans V. Predictors of calcification distribution in severe tricuspid aortic valve stenosis. Int J Cardiovasc Imaging. 2021 Sep;37(9):2791-2799. doi: 10.1007/s10554-021-02248-6. Epub 2021 Apr 20.
- Derived from this study: PubMed 33380924Veulemans V, Maier O, Bosbach G, Hellhammer K, Afzal S, Piayda K, Polzin A, Jung C, Westenfeld R, Mehdiani A, Lichtenberg A, Kelm M, Zeus T. Impact of Combined "CHADS-BLED" Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement. J Interv Cardiol. 2020 Dec 18;2020:9414397. doi: 10.1155/2020/9414397. eCollection 2020.
- Derived from this study: PubMed 31838114Piayda K, Hellhammer K, Veulemans V, Sievert H, Gafoor S, Afzal S, Hennig I, Makosch M, Polzin A, Jung C, Westenfeld R, Kelm M, Zeus T. Navigating the "Optimal Implantation Depth" With a Self-Expandable TAVR Device in Daily Clinical Practice. JACC Cardiovasc Interv. 2020 Mar 23;13(6):679-688. doi: 10.1016/j.jcin.2019.07.048. Epub 2019 Dec 11.
- Derived from this study: PubMed 27073910Veulemans V, Zeus T, Kleinebrecht L, Balzer J, Hellhammer K, Polzin A, Horn P, Blehm A, Minol JP, Kropil P, Westenfeld R, Rassaf T, Lichtenberg A, Kelm M. Comparison of Manual and Automated Preprocedural Segmentation Tools to Predict the Annulus Plane Angulation and C-Arm Positioning for Transcatheter Aortic Valve Replacement. PLoS One. 2016 Apr 13;11(4):e0151918. doi: 10.1371/journal.pone.0151918. eCollection 2016.
- Derived from this study: PubMed 24755302Balzer JC, Boering YC, Mollus S, Schmidt M, Hellhammer K, Kroepil P, Westenfeld R, Zeus T, Antoch G, Linke A, Steinseifer U, Merx MW, Kelm M. Left ventricular contrast injection with rotational C-arm CT improves accuracy of aortic annulus measurement during cardiac catheterisation. EuroIntervention. 2014 Jul;10(3):347-54. doi: 10.4244/EIJV10I3A60.
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, MD study director
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malte Kelm, MD (0049 211 81 18800, CTSU@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of diameters of the aortic annulus using the different imaging modalities (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805739, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.