Brief Title
Impact of SAVR and TAVR on Patient's Activity and Mobility
Official Title
Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study
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.
Study Type
Observational
Primary Outcome
6-minute walk test (6 MWT) at 1 month
Secondary Outcome
validity of the device in measuring physical function
Condition
Aortic Valve Stenosis
Intervention
SAPIEN 3
Study Arms / Comparison Groups
SAVR
Description: Patients with aortic stenosis undergoing surgical aortic valve replacement using an approved medical device for this intended use. Patients will be enrolled in this group only if the device is one of the following: INSPIRIS RESILIA; EDWARDS INTUITY; Carpentier-Edwards PERIMOUNT Magna-Ease.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
340
Start Date
December 2021
Completion Date
December 2024
Primary Completion Date
December 2023
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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.
Gender
All
Ages
75 Years - 89 Years
Accepts Healthy Volunteers
No
Contacts
Giuseppe Tarantini, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03843320
Organization ID
CAPABILITY
Responsible Party
Sponsor
Study Sponsor
University of Padova
Collaborators
Edwards Lifesciences
Study Sponsor
Giuseppe Tarantini, MD, Principal Investigator, University of Padova
Verification Date
December 2020