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

University of Padova

Status: Suspended

Conditions: Aortic Valve Stenosis

Treatments: Device: Carpentier-Edwards PERIMOUNT Magna-Ease; Device: EDWARDS INTUITY; Device: INSPIRIS RESILIA; Device: SAPIEN 3; Device: SAPIEN XT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03843320

CAPABILITY

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 75 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

340 participants in 2 patient 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.

Treatment:

Device: Carpentier-Edwards PERIMOUNT Magna-Ease

Device: EDWARDS INTUITY

Device: INSPIRIS RESILIA

TAVR

Description:

Patients with aortic stenosis undergoing transcatheter 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: * SAPIEN 3; * SAPIEN XT.

Treatment:

Device: SAPIEN 3

Device: SAPIEN XT