Status:
SUSPENDED
Impact of SAVR and TAVR on Patient's Activity and Mobility
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Edwards Lifesciences
Ospedale San Bortolo di Vicenza
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
75-89 years
Brief Summary
This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physica...
Eligibility Criteria
Inclusion
- Severe native aortic valve stenosis symptomatic for heart failure or angina;
- Indication to isolated TAVR or SAVR given by heart team;
- TAVR through the trans-femoral approach;
- SAVR by any access;
- Implantation of an Edwards valve type (SAPIEN 3 and SAPIEN XT for TAVR; INSPIRIS RESILIA, EDWARDS INTUITY and Carpentier-Edwards PERIMOUNT Magna-Ease for SAVR);
- Signed informed consent.
Exclusion
- Use of walking aids;
- Dyskinesia or Parkinson's disease;
- Reduced survival expectancy due to severe co-morbidities (\<1 year);
- Lack of any of inclusion criteria.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03843320
Start Date
December 1 2021
End Date
December 1 2024
Last Update
December 3 2020
Active Locations (2)
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1
Azienda Ospedaliera di Padova
Padua, PD, Italy, 35128
2
Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo
Vicenza, VI, Italy