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The Nordic Aortic Valve Intervention Trial

NCT01057173 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2023-11-22

No results posted yet for this study

Summary

A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.

Study hypothesis: TAVI will reduce post-interventional morbidity and mortality compared to SAVR.

Conditions

  • Critical Aortic Stenosis

Interventions

PROCEDURE

Transcatheter Aortic Valve Implantation

Retrograde trans-femoral or trans-subclavian aortic valve implantation with the Medtronic CoreValve System(TM) bio-prosthesis (third generation system, 18 Fr, CE mark approved)

PROCEDURE

Surgical Aortic Valve Replacement

Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Danish Heart Foundation

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Hans GH Thyregod, MD, PhD · Dep. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital

  • Lars Søndergaard, MD, DMSc · Dep. of Cardiology, Rigshospitalet, Copenhagen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-04-30
Completion
2033-04-30

Countries

  • Denmark
  • Sweden

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 NCT01057173 on ClinicalTrials.gov