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Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

NCT03972644 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2020-09-14

No results posted yet for this study

Summary

The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.

Conditions

  • Aortic Valve Stenosis
  • Diastolic Dysfunction

Interventions

PROCEDURE

Aortic valve replacement

Open heart surgery or transcatheter surgery

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2029-09-01
Completion
2029-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972644 on ClinicalTrials.gov