Impact of SAVR and TAVR on Patient's Activity and Mobility
NCT ID: NCT03843320
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
340 participants
OBSERVATIONAL
2021-12-31
2024-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SAVR
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.
INSPIRIS RESILIA
Surgical aortic valve replacement
EDWARDS INTUITY
Surgical aortic valve replacement
Carpentier-Edwards PERIMOUNT Magna-Ease
Surgical aortic valve replacement
TAVR
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.
SAPIEN 3
Transcatheter aortic valve replacement
SAPIEN XT
Transcatheter aortic valve replacement
Interventions
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SAPIEN 3
Transcatheter aortic valve replacement
SAPIEN XT
Transcatheter aortic valve replacement
INSPIRIS RESILIA
Surgical aortic valve replacement
EDWARDS INTUITY
Surgical aortic valve replacement
Carpentier-Edwards PERIMOUNT Magna-Ease
Surgical aortic valve replacement
Eligibility Criteria
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Inclusion Criteria
* 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
* Dyskinesia or Parkinson's disease;
* Reduced survival expectancy due to severe co-morbidities (\<1 year);
75 Years
89 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Ospedale San Bortolo di Vicenza
OTHER
Azienda Ospedaliera di Padova
OTHER
University of Padova
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Tarantini, MD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
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Azienda Ospedaliera di Padova
Padua, PD, Italy
Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo
Vicenza, VI, Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CAPABILITY
Identifier Type: -
Identifier Source: org_study_id