Aortic StenosisTAVR-CMRNCT03831087
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
A study testing TAVR-CMR and TAVR-CT in people with Aortic Stenosis, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVR-CMR and TAVR-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteAustria
- Study dates
- 30 Oct 2017to 5 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1)
- Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope
- Patient is evaluated for TAVR
Who cannot join
- Contraindications to perform CMR
- Contraindications to perform CT
- Contraindications for TAVR or reduced life expectancy < 1 year.
- Known hypersensitivity to CMR or CT contrast agents
- Childbearing potential or inability to exclude pregnancy
- Inability to understand and follow study-related instructions
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- Severe renal insufficiency requiring renal replacement therapy
- Severe hepatic insufficiency (Child-Pugh class B or C)
- Post organ transplantation
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Clinic of Internal Medicine III
Innsbruck, Tyrol, 6020
About this study
Official title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
Read the detailed description
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR).
Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University.
Planned Study Period: 2017-2023.
Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.
Design: Prospective, randomized, open-label, multi-centre trial.
Patients (planned): 270 patients.
Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision.
Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion.
Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after 6 months. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 6 months, as well as a comparison of imaging procedure related variables (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus document.
- Conditions
- Aortic Stenosis
- Being tested
- TAVR-CMR, TAVR-CT
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR-CMRDiagnostic test
CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
TAVR-CTDiagnostic test
CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
| Study group | Role | What they receive |
|---|---|---|
| TAVR-CMR | Other | All MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D "whole-heart" coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA. Receives: Diagnostic Test: TAVR-CMR |
| TAVR-CT | Other | All CT examinations will be performed on a 128-slice dual-source CT and high-pitch factor. Prospective electrocardiographic synchronization will be applied, triggered into the diastolic phase for the heart. An injected bolus of 70 to 110 mL of nonionic iodine contrast agent will be applied with 370 mg/mL iodine concentration, using an automatic injector at a flow rate of 5 mL/s, followed by 40 mL saline solution. Contrast agent volume for each patient will be calculated by scan time and body weight. Patients will be placed supine with arms overhead. The scan length range from supraaortic branches to the groins. Receives: Diagnostic Test: TAVR-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient < 20mmHg and no valve regurgitation > mild)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start30 Oct 2017
- Primary completion5 Aug 2023
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Kepler University of Linz, Klinikum Wels-Grieskirchen
- Responsible party
- Sponsor
- Investigators
- Bernhard Metzler, Prof., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831087
- Sponsor's protocol ID
- 20171002-1653
- Acronym
- TAVR-CMR
- Status last verified
- Aug 2023
- First submitted
- 4 Feb 2019
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lechner I, Oberhollenzer F, Tiller C, Holzknecht M, Kaser A, Binder RK, Gollmann-Tepekoylu C, Klug G, Mayr A, Bauer A, Metzler B, Reindl M, Reinstadler SJ. Age and sex-related outcomes in cardiovascular magnetic resonance versus computed tomography-guided transcatheter aortic valve replacement: a secondary analysis of a randomized clinical trial. J Cardiovasc Magn Reson. 2025 Summer;27(1):101882. doi: 10.1016/j.jocmr.2025.101882. Epub 2025 Mar 13.
PubMed 40089160Reindl M, Lechner I, Holzknecht M, Tiller C, Fink P, Oberhollenzer F, von der Emde S, Pamminger M, Troger F, Kremser C, Lassnig E, Danninger K, Binder RK, Ulmer H, Brenner C, Klug G, Bauer A, Metzler B, Mayr A, Reinstadler SJ. Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2023 Oct 17;148(16):1220-1230. doi: 10.1161/CIRCULATIONAHA.123.066498. Epub 2023 Aug 27.
PubMed 37634187Klug G, Reinstadler S, Troger F, Holzknecht M, Reindl M, Tiller C, Lechner I, Fink P, Pamminger M, Kremser C, Ulmer H, Bauer A, Metzler B, Mayr A. Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR). Trials. 2022 Sep 2;23(1):726. doi: 10.1186/s13063-022-06638-6.
PubMed 36056444
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT03831087
- Acronym / sponsor ID
- TAVR-CMR / 20171002-1653
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Johannes Kepler University of Linz, Klinikum Wels-Grieskirchen
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 5 Feb 2019 (actual)
- 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.
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
Detailed description
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR).
Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University.
Planned Study Period: 2017-2023.
Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.
Design: Prospective, randomized, open-label, multi-centre trial.
Patients (planned): 270 patients.
Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision.
Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion.
Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after 6 months. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 6 months, as well as a comparison of imaging procedure related variables (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus document.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR-CMR | Other | Diagnostic Test: TAVR-CMRAll MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D "whole-heart" coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA. |
| TAVR-CT | Other | Diagnostic Test: TAVR-CTAll CT examinations will be performed on a 128-slice dual-source CT and high-pitch factor. Prospective electrocardiographic synchronization will be applied, triggered into the diastolic phase for the heart. An injected bolus of 70 to 110 mL of nonionic iodine contrast agent will be applied with 370 mg/mL iodine concentration, using an automatic injector at a flow rate of 5 mL/s, followed by 40 mL saline solution. Contrast agent volume for each patient will be calculated by scan time and body weight. Patients will be placed supine with arms overhead. The scan length range from supraaortic branches to the groins. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1)
- Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope
- Patient is evaluated for TAVR
Key exclusion criteria (10 listed)
- Contraindications to perform CMR
- Contraindications to perform CT
- Contraindications for TAVR or reduced life expectancy < 1 year.
- Known hypersensitivity to CMR or CT contrast agents
- Childbearing potential or inability to exclude pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR-CMRCMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route. | Diagnostic test | TAVR-CMR |
| TAVR-CTCT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route. | Diagnostic test | TAVR-CT |
Primary outcome
The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
Time frame: 6 months
The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient < 20mmHg and no valve regurgitation > mild)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 40089160Lechner I, Oberhollenzer F, Tiller C, Holzknecht M, Kaser A, Binder RK, Gollmann-Tepekoylu C, Klug G, Mayr A, Bauer A, Metzler B, Reindl M, Reinstadler SJ. Age and sex-related outcomes in cardiovascular magnetic resonance versus computed tomography-guided transcatheter aortic valve replacement: a secondary analysis of a randomized clinical trial. J Cardiovasc Magn Reson. 2025 Summer;27(1):101882. doi: 10.1016/j.jocmr.2025.101882. Epub 2025 Mar 13.
- Derived from this study: PubMed 37634187Reindl M, Lechner I, Holzknecht M, Tiller C, Fink P, Oberhollenzer F, von der Emde S, Pamminger M, Troger F, Kremser C, Lassnig E, Danninger K, Binder RK, Ulmer H, Brenner C, Klug G, Bauer A, Metzler B, Mayr A, Reinstadler SJ. Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2023 Oct 17;148(16):1220-1230. doi: 10.1161/CIRCULATIONAHA.123.066498. Epub 2023 Aug 27.
- Derived from this study: PubMed 36056444Klug G, Reinstadler S, Troger F, Holzknecht M, Reindl M, Tiller C, Lechner I, Fink P, Pamminger M, Kremser C, Ulmer H, Bauer A, Metzler B, Mayr A. Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR). Trials. 2022 Sep 2;23(1):726. doi: 10.1186/s13063-022-06638-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bernhard Metzler, Prof. principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR-CMR and TAVR-CT in people with Aortic Stenosis, run by Medical University Innsbruck at 1 site in Austria.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 9 Aug 2023. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria. (time frame: 6 months). 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 NCT03831087, which also lists 3 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 9 Aug 2023.