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Clinical Trials/NCT06129799
NCT06129799
Recruiting
Not Applicable

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

University of Göttingen1 site in 1 country100 target enrollmentNovember 1, 2023
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ConditionsAortic Stenosis, Severe

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis, Severe
Sponsor
University of Göttingen
Enrollment
100
Locations
1
Primary Endpoint
Composite of events: number of participants with cardiovascular death or heart failure hospitalisation
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Göttingen
Responsible Party
Principal Investigator
Principal Investigator

Sören Backhaus

Principal Investigator

University of Göttingen

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

Outcomes

Primary Outcomes

Composite of events: number of participants with cardiovascular death or heart failure hospitalisation

Time Frame: 12 months

Study Sites (1)

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