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Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

NCT04810195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 554

Last updated 2022-10-05

No results posted yet for this study

Summary

The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Boston Scientific Acurate neo2 TAVR device

The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Andreas Rück

    lead OTHER

Principal Investigators

  • Andreas Rück, MD PhD · Karolinska University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-04-01
Completion
2022-03-15
FDA Device
Yes

Countries

  • Denmark
  • Germany
  • 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 NCT04810195 on ClinicalTrials.gov