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

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

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 Overview

• Status: Suspended
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: INSPIRIS RESILIA; Device: EDWARDS INTUITY; Device: Carpentier-Edwards PERIMOUNT Magna-Ease; Device: SAPIEN 3; Device: SAPIEN XT

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padova, PD, Italy, 35128
      • Azienda Ospedaliera di Padova
  • VI
    • Vicenza, VI, Italy
      • Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 89 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TAVR or SAVR

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Surgical aortic valve replacement; Device: EDWARDS INTUITY; Surgical aortic valve replacement; Device: 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.	Device: SAPIEN 3; Transcatheter aortic valve replacement; Device: SAPIEN XT; Transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
validity of the device in measuring physical function	Differences of length between device measurements and observer measurements of the 6-minute walk test (6MWT)	1, 3, 6 and 12 months after treatment with TAVR/SAVR
patients' compliance with the device	median hours/day ratio of data recorded combined with the median days/month ratio in which the device was actively collecting data; formula is [(h/d)*(d/m)]	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)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health status, consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The SF-36 Health Survey items and scales were constructed using the Likert method of summated ratings. Answers to each question are scored (some items need to be recoded). These scores are then summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale.	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)	The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a 16-item, patient reported survey of patient health status, consists of sixteen questions with a 7-point Likert scale answer. The score is the sum of the answer and transformed into a 0-100 scale. The lower the score the better quality of life, the higher the score the worst quality of life.	1, 3, 6 and 12 months after treatment with TAVR/SAVR
Sleep quality assessed by the Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. This can be helpful in diagnosing sleep disorders. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations. The scores for the eight questions are added together to obtain a single number (0-24) where the lowest is the better outcome: a number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.	1, 3, 6 and 12 months after treatment with TAVR/SAVR
Cognitive function assessed by the Mini Mental State Examination (MMSE)	The Mini Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. Administration of the test takes between 5 and 10 minutes and examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age	1, 3, 6 and 12 months after treatment with TAVR/SAVR

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Edwards Lifesciences; Azienda Ospedaliera di Padova; Ospedale San Bortolo di Vicenza
• Investigators: Principal Investigator: Giuseppe Tarantini, MD, University of Padova

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Physical function; TAVR; Wearable devices; Aortic valve replacement; SAVR; Smart watch; Activity tracker
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CAPABILITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes