Impact of SAVR and TAVR on Patient's Activity and Mobility

NCT03843320 | Suspended DMC FDA Device

• 1 other identifier: CAPABILITY
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Valve Stenosis

Keywords

SAVR; TAVR; Physical function; Aortic valve replacement; Wearable devices; Smart watch; Activity tracker

Outcome Measures

Primary Outcomes (3)

• 6-minute walk test (6 MWT) at 1 month

  The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  1 month after treatment with TAVR/SAVR

• 6-minute walk test (6 MWT) at 3 months

  The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  3 months after treatment with TAVR/SAVR

• 6-minute walk test (6 MWT) at 6 months

  The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  6 months after treatment with TAVR/SAVR

Secondary Outcomes (6)

• validity of the device in measuring physical function

  1, 3, 6 and 12 months after treatment with TAVR/SAVR

• patients' compliance with the device

  1, 3, 6 and 12 months after treatment with TAVR/SAVR

• Patient's perceived health status assessed by the 36-Item Short Form Survey (SF-36)

  1, 3, 6 and 12 months after treatment with TAVR/SAVR

• Health related Quality of Life (HRQoL) assessed by the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ)

  1, 3, 6 and 12 months after treatment with TAVR/SAVR

• Sleep quality assessed by the Epworth Sleepiness Scale (ESS)

  1, 3, 6 and 12 months after treatment with TAVR/SAVR

Study Arms (2)

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.

Device: INSPIRIS RESILIA; Device: EDWARDS INTUITY; Device: Carpentier-Edwards PERIMOUNT Magna-Ease

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.

Device: SAPIEN 3; Device: SAPIEN XT

Interventions

SAPIEN 3 DEVICE

Transcatheter aortic valve replacement

TAVR

SAPIEN XT DEVICE

Transcatheter aortic valve replacement

TAVR

INSPIRIS RESILIA DEVICE

Surgical aortic valve replacement

SAVR

EDWARDS INTUITY DEVICE

Surgical aortic valve replacement

SAVR

Carpentier-Edwards PERIMOUNT Magna-Ease DEVICE

Surgical aortic valve replacement

SAVR

Eligibility Criteria

• Age: 75 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TAVR or SAVR

You may qualify if:

• 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.

You may not qualify if:

• Use of walking aids;
• Dyskinesia or Parkinson's disease;
• Reduced survival expectancy due to severe co-morbidities (\<1 year);

Sponsors & Collaborators

• University of Padova: lead
• Edwards Lifesciences: collaborator
• Ospedale San Bortolo di Vicenza: collaborator
• Azienda Ospedaliera di Padova: collaborator

Study Sites (2)

Azienda Ospedaliera di Padova

Padua, PD, 35128, Italy

Location

Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo

Vicenza, VI, Italy

Location

Related Publications (4)

• 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.

  PMID: 16980116 BACKGROUND

• 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.

  PMID: 23229811 BACKGROUND

• 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.

  PMID: 22917726 BACKGROUND

• 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.

  PMID: 33180023 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Giuseppe Tarantini, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 18, 2019
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)