NCT03843320

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

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 75 Years – 89 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2019-02-18
• Last updated: 2020-12-03

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated device study