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Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality

NCT03112980 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1414

Last updated 2026-05-15

No results posted yet for this study

Summary

Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Transcatheter aortic valve implantation

(TAVI)

PROCEDURE

Surgical aortic valve replacement

(SAVR)

Sponsors & Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • The German Heart Foundation

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Stefan Blankenberg, MD · Universitäres Herz- und Gefäßzentrum Hamburg (UHZ), Germany

  • Jochen Cremer, MD · Universitätsklinikum Schleswig-Holstein, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Germany

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 NCT03112980 on ClinicalTrials.gov