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Exercise CMR in (p)LF-LG AS

Sponsor
University of Göttingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT06129799
Collaborator
(none)
100
Enrollment
1
Location
38
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis
    Actual Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    paradoxical LF-LG AS
    conventional LF-LG AS

    Outcome Measures

    Primary Outcome Measures

    1. Composite of events: number of participants with cardiovascular death or heart failure hospitalisation [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Goettingen Göttingen Germany 37073

    Sponsors and Collaborators

    • University of Göttingen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sören Backhaus, Principal Investigator, University of Göttingen
    ClinicalTrials.gov Identifier:
    NCT06129799
    Other Study ID Numbers:
    • 16822
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Nov 13, 2023