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Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

NCT01852552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 518

Last updated 2016-11-15

No results posted yet for this study

Summary

Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).

The objectives of the study are:

1. Description of neurocognitive status before and after transcatheter aortic valve implantation and aortic valve replacement procedures
2. Description of Quality of Life (QoL) after these procedures
3. Defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities
4. Assessment of costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and costs of follow-up.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

transcatheter aortic valve implantation

Patients undergoing TAVI with transfemoral, transapical, or any other vascular access

PROCEDURE

Aortic Valve Replacement

Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Region Emilia-Romagna, Italy

    collaborator UNKNOWN

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Italy

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 NCT01852552 on ClinicalTrials.gov