Clinical trial NCT03843320: 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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Aortic Valve Stenosis
Keywords: SAVR
TAVR
Physical function
Aortic valve replacement
Wearable devices
Smart watch
Activity tracker
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: Ospedale San Bortolo di Vicenza
name: Azienda Ospedaliera di Padova
First posted: 2019-02-18
Enrollment: 340
Sex: ALL
Minimum age (years): 75
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing TAVR or SAVR

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.


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.

Primary outcomes:
measure: 6-minute walk test (6 MWT) at 1 month
timeFrame: 1 month after treatment with TAVR/SAVR
measure: 6-minute walk test (6 MWT) at 3 months
timeFrame: 3 months after treatment with TAVR/SAVR
measure: 6-minute walk test (6 MWT) at 6 months
timeFrame: 6 months after treatment with TAVR/SAVR
Secondary outcomes:
measure: validity of the device in measuring physical function
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
measure: patients' compliance with the device
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
measure: Patient's perceived health status assessed by the 36-Item Short Form Survey (SF-36)
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
measure: Health related Quality of Life (HRQoL) assessed by the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ)
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
measure: Sleep quality assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
measure: Cognitive function assessed by the Mini Mental State Examination (MMSE)
timeFrame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: PD
city: Vicenza
country: Italy
facility: Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo
state: VI
Study officials:
affiliation: University of Padova
name: Giuseppe Tarantini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
citation: van Geldorp MW, Heuvelman HJ, Kappetein AP, Busschbach JJ, Cohen DJ, Takkenberg JJ, Bogers AJ. Quality of life among patients with severe aortic stenosis. Neth Heart J. 2013 Jan;21(1):21-7. doi: 10.1007/s12471-012-0364-9.
citation: Stortecky S, Schmid V, Windecker S, Kadner A, Pilgrim T, Buellesfeld L, Khattab AA, Wenaweser P. Improvement of physical and mental health after transfemoral transcatheter aortic valve implantation. EuroIntervention. 2012 Aug;8(4):437-43. doi: 10.4244/EIJV8I4A69.
citation: Lorenzoni G, Azzolina D, Fraccaro C, Di Liberti A, D'Onofrio A, Cavalli C, Fabris T, D'Amico G, Cibin G, Nai Fovino L, Ocagli H, Gerosa G, Tarantini G, Gregori D. Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study. JMIR Res Protoc. 2020 Nov 12;9(11):e20072. doi: 10.2196/20072.