Aortic Valve StenosisNCT03107923
Better Patient Selection to Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis and Left Ventricular Dysfunction, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Left Ventricular Dysfunction, Myocardial Fibrosis
- What is being tested?
- Dobutamine stress test
- How many people
- 103 participants
- Where
- 2 sitesNorway
- Study dates
- 26 Apr 2017to 31 Mar 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet
Who may be able to join
- Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.
Who cannot join
- Aortic valve endocarditis
- aortic annulus >31mm
- preoperative pacemaker
- severe aortic insufficiency (>grad 3)
- rapid atrial fibrillation
- unprotected left main coronary stenosis not suitable for percutaneous intervention.
Show all 11Show fewer
- unstable angina
- life expectancy less than 12 months
- mental disorder including dementia and condition which interferes with protocol compliance.
- renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
- Patients with metal not suitable for MRI.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo Universtity Hospital
Oslo, 0424
The Intervention Centre
Oslo, 0424
About this study
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.
Read the detailed description
In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.
- Being tested
- Dobutamine stress test
- Keywords
- Myocardial fibrosis, Aortic Valve Stenosis, TAVI, Outcome
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine stress testDiagnostic test
Test of myocardial reserve
| Study group | Role | What they receive |
|---|---|---|
| Preoperative myocardial reserve yes/no | Patients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test. Receives: Diagnostic Test: Dobutamine stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death
Measured: 1 year
Secondary outcomes (3)
NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome
Number of Participants hospitalizated for heart related diseases during 12 month follow-up.
Measured: 1 year
Patient quality of life (QoL)
Quality of life record (SF 36), Physical function (age adjusted normal value 71.6 (SD 26.9)) and Physical role (age adjusted normal value 57.0 (SD 43.8)) , the patients were divided into groups using the predefined minimal change of 15 and 18,75 points, respectively. Changes above these tresholds at 12 month follow-up indicat better QoL outcomes.
Measured: 1 year
6 Minute Walking Test
Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start26 Apr 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
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 Valve StenosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Steinar Halvorsen, Oslo University Hospital
- Investigators
- Erik Fosse, Professor, Study director, The Intervention Centre, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107923
- Sponsor's protocol ID
- 535444
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, Hamm C, Kappetein AP, Leipsic J, Leon MB, MacCarthy P, Piazza N, Pibarot P, Roberts WC, Rodes-Cabau J, Serruys PW, Thomas M, Vahanian A, Webb J, Zamorano JL, Windecker S. Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. Eur Heart J. 2014 Oct 7;35(38):2627-38. doi: 10.1093/eurheartj/ehu256. Epub 2014 Jul 25.
PubMed 25062952Eidet J, Dahle G, Bugge JF, Bendz B, Rein KA, Aaberge L, Offstad JT, Fosse E, Aakhus S, Halvorsen PS. Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):403-9. doi: 10.1093/icvts/ivw159. Epub 2016 May 30.
PubMed 27241050Saevik M, Andersen MH, Beitnes JO, Aaberge L, Halvorsen PS. Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months. J Patient Rep Outcomes. 2025 May 26;9(1):58. doi: 10.1186/s41687-025-00894-1.
PubMed 40418351
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Patient Selection to Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT03107923
- Acronym / sponsor ID
- 535444
- Keywords
- Myocardial fibrosis, Aortic Valve Stenosis, TAVI, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Apr 2017 (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.
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.
Detailed description
In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative myocardial reserve yes/no | – | Diagnostic Test: Dobutamine stress testPatients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet
Key inclusion criteria (1 listed)
- Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.
Key exclusion criteria (11 listed)
- Aortic valve endocarditis
- aortic annulus >31mm
- preoperative pacemaker
- severe aortic insufficiency (>grad 3)
- rapid atrial fibrillation
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 |
|---|---|---|
| Dobutamine stress testTest of myocardial reserve | Diagnostic test | Preoperative myocardial reserve yes/no |
Primary outcome
MACE
Time frame: 1 year
MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death
3 secondary outcomes
NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome
Time frame: 1 year
Patient quality of life (QoL)
Time frame: 1 year
6 Minute Walking Test
Time frame: 1 year
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 29 Jun 2023.
- Background: PubMed 25062952Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, Hamm C, Kappetein AP, Leipsic J, Leon MB, MacCarthy P, Piazza N, Pibarot P, Roberts WC, Rodes-Cabau J, Serruys PW, Thomas M, Vahanian A, Webb J, Zamorano JL, Windecker S. Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. Eur Heart J. 2014 Oct 7;35(38):2627-38. doi: 10.1093/eurheartj/ehu256. Epub 2014 Jul 25.
- Background: PubMed 27241050Eidet J, Dahle G, Bugge JF, Bendz B, Rein KA, Aaberge L, Offstad JT, Fosse E, Aakhus S, Halvorsen PS. Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):403-9. doi: 10.1093/icvts/ivw159. Epub 2016 May 30.
- Derived from this study: PubMed 40418351Saevik M, Andersen MH, Beitnes JO, Aaberge L, Halvorsen PS. Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months. J Patient Rep Outcomes. 2025 May 26;9(1):58. doi: 10.1186/s41687-025-00894-1.
- 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.
Erik Fosse, Professor study director
The Intervention Centre, Oslo University Hospital
2 sites 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 and Left Ventricular Dysfunction, run by Oslo University Hospital at 2 sites in Norway.
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 1 inclusion and 11 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
MACE (time frame: 1 year). 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 NCT03107923, 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 29 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.