Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03843320
Status:
SUSPENDED
Last Update Posted:
2020-12-03
First Post:
2019-01-24
Brief Title:
Impact of SAVR and TAVR on Patients Activity and Mobility
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Impact of SAVR and TAVR on Patients Activity and Mobility CAPABILITY Study
Status:
SUSPENDED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reassessing study feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPABILITY
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None