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Recruiting NCT06129799

Exercise CMR in (p)LF-LG AS

Observational Aortic Stenosis, Severe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Stenosis, Severe. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis

Overview

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.

Primary outcome measures

  • Composite of events: number of participants with cardiovascular death or heart failure hospitalisation [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • paradoxical or conventional severe low-flow low-gradient aortic stenosis

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • University Hospital Goettingen — Göttingen

Identifiers

NCT: NCT06129799 · 16822

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗