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

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ClinicalTrials.gov Identifier: NCT03843320
Recruitment Status : Suspended (Reassessing study feasibility)
First Posted : February 18, 2019
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Edwards Lifesciences
Ospedale San Bortolo di Vicenza
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova

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.


Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: SAPIEN 3 Device: SAPIEN XT Device: INSPIRIS RESILIA Device: EDWARDS INTUITY Device: Carpentier-Edwards PERIMOUNT Magna-Ease

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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 6-minute walk test (6 MWT) at 1 month [ Time Frame: 1 month after treatment with TAVR/SAVR ]
    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.

  2. 6-minute walk test (6 MWT) at 3 months [ Time Frame: 3 months after treatment with TAVR/SAVR ]
    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. 6-minute walk test (6 MWT) at 6 months [ Time Frame: 6 months after treatment with TAVR/SAVR ]
    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.


Secondary Outcome Measures :
  1. validity of the device in measuring physical function [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]
    Differences of length between device measurements and observer measurements of the 6-minute walk test (6MWT)

  2. patients' compliance with the device [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]
    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)]

  3. Patient's perceived health status assessed by the 36-Item Short Form Survey (SF-36) [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]

    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.


  4. Health related Quality of Life (HRQoL) assessed by the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]
    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.

  5. Sleep quality assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]

    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.


  6. Cognitive function assessed by the Mini Mental State Examination (MMSE) [ Time Frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing TAVR or SAVR
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843320


Locations
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Italy
Azienda Ospedaliera di Padova
Padova, PD, Italy, 35128
Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo
Vicenza, VI, Italy
Sponsors and Collaborators
University of Padova
Edwards Lifesciences
Ospedale San Bortolo di Vicenza
Azienda Ospedaliera di Padova
Investigators
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Principal Investigator: Giuseppe Tarantini, MD University of Padova
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT03843320    
Other Study ID Numbers: CAPABILITY
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Padova:
SAVR
TAVR
Physical function
Aortic valve replacement
Wearable devices
Smart watch
Activity tracker
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction