Aortic Stenosis, SevereNCT06129799
Exercise CMR in (p)LF-LG AS
An observational study of Aortic Stenosis, Severe, run by University of Göttingen at 1 site in Germany.
Trial summary
Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 31 Dec 2026
- 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 prior to TAVR
Who may be able to join
- paradoxical or conventional severe low-flow low-gradient aortic stenosis
Who cannot join
- CMR incapable device
- unable to undergo 40 min scan (can not lie flat, claustrophobia)
- renal insufficiency (eGFR <30 ml/min/1.73m²)
- allergy against contrast agent
- unable to exercise in supine position
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
University Hospital Goettingen
Göttingen, 37073
Sören Backhaus, MD, 00495513966315, soeren.backhaus@med.uni-goettingen.de
About this study
Official title: Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis
Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.
- Conditions
- Aortic Stenosis, Severe
- 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.
| Study group | Role | What they receive |
|---|---|---|
| paradoxical LF-LG AS | Not described | |
| conventional LF-LG AS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of events: number of participants with cardiovascular death or heart failure hospitalisation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sören Backhaus, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129799
- Sponsor's protocol ID
- 16822
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06129799
- Acronym / sponsor ID
- 16822
- Conditions
- Aortic Stenosis, Severe
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2023 (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.
Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paradoxical LF-LG AS | – | – |
| conventional LF-LG AS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prior to TAVR
Key inclusion criteria (1 listed)
- paradoxical or conventional severe low-flow low-gradient aortic stenosis
Key exclusion criteria (5 listed)
- CMR incapable device
- unable to undergo 40 min scan (can not lie flat, claustrophobia)
- renal insufficiency (eGFR <30 ml/min/1.73m²)
- allergy against contrast agent
- unable to exercise in supine position
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
Composite of events: number of participants with cardiovascular death or heart failure hospitalisation
Time frame: 12 months
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 13 Nov 2023.
Related trials for Aortic Stenosis, Severe
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
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.
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 Stenosis, Severe, run by University of Göttingen 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 1 inclusion and 5 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 13 Nov 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of events: number of participants with cardiovascular death or heart failure hospitalisation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.