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Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

NCT02825134 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2024-04-09

No results posted yet for this study

Summary

A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.

Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.

Conditions

  • Aortic Valve Stenosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Ventricular Outflow Obstruction

Interventions

DEVICE

Transcatheter aortic valve replacement

Retrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention.

DEVICE

Surgical aortic valve replacement

Conventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery.

Sponsors & Collaborators

  • Symetis SA

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Ole De Backer

    lead OTHER

Principal Investigators

  • Ole De Backer, MD; PhD · Rigshospitalet, Denmark

  • Hans GH Thyregod, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2024-02-29
Completion
2029-06-30

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

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Entities

Diseases
Companies

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 NCT02825134 on ClinicalTrials.gov