Impact of SAVR and TAVR on Patient's Activity and Mobility

Summary

This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing aortic stenosis (AS) treatment with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) implanted with Edwards valve type ("SAPIEN 3" and "SAPIEN XT" for TAVR; "INSPIRIS RESILIA", "EDWARDS INTUITY" and "Carpentier-Edwards PERIMOUNT Magna-Ease" for SAVR).

Secondary objectives of this study are: to evaluate the validity of wearable devices in assessing physical function in such patients and subjects' compliance in wearing the device also after a very long follow-up time up to 12 months; to assess and compare 6-month postoperative changes in Health-Related Quality of Life (HRQoL), sleep quality, cognitive function of patients undergoing AS treatment with either TAVR or SAVR.

Smart watch activity tracker "Vívoactive® HR" devices by "Garmin©" will be used in the study. Devices will be distributed to the patients at time of baseline assessment, along with a Bluetooth-paired smartphone provided with a prepaid data-only SIM-card and study-customised interface. Patients will be asked to wear the device 24 hours a day, 7 days a week, from the baseline assessment to the last follow-up, 12 months after baseline.

Conditions

• Aortic Valve Stenosis

Interventions

DEVICE

SAPIEN 3

Transcatheter aortic valve replacement

DEVICE

SAPIEN XT

Transcatheter aortic valve replacement

DEVICE

INSPIRIS RESILIA

Surgical aortic valve replacement

DEVICE

EDWARDS INTUITY

Surgical aortic valve replacement

DEVICE

Carpentier-Edwards PERIMOUNT Magna-Ease

Surgical aortic valve replacement

Sponsors & Collaborators

• Edwards Lifesciences

  collaborator INDUSTRY

• Ospedale San Bortolo di Vicenza

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• University of Padova

  lead OTHER

Principal Investigators

• Giuseppe Tarantini, MD · University of Padova

Eligibility

Min Age

75 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2023-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• Italy

Study Locations