Aortic Valve StenosisCAPABILITYNCT03843320
Impact of SAVR and TAVR on Patient's Activity and Mobility
An observational study of Aortic Valve Stenosis, run by University of Padova at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 to 89 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- SAPIEN 3, SAPIEN XT and INSPIRIS RESILIA
- Type of treatment
- Medical device
- How many people
- 340 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing TAVR or SAVR
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera di Padova
Padova, PD, 35128
Azienda ULSS n.8 Berica, Vicenza - Ospedale San Bortolo
Vicenza, VI
About this study
Official title: 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- SAPIEN 3, SAPIEN XT, INSPIRIS RESILIA, EDWARDS INTUITY, Carpentier-Edwards PERIMOUNT Magna-Ease
- Keywords
- SAVR, TAVR, Physical function, Aortic valve replacement, Wearable devices, Smart watch, Activity tracker
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN 3Device
Transcatheter aortic valve replacement
SAPIEN XTDevice
Transcatheter aortic valve replacement
INSPIRIS RESILIADevice
Surgical aortic valve replacement
EDWARDS INTUITYDevice
Surgical aortic valve replacement
Carpentier-Edwards PERIMOUNT Magna-EaseDevice
Surgical aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: SAPIEN 3; Device: SAPIEN XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after treatment with TAVR/SAVR
Secondary outcomes (6)
validity of the device in measuring physical function
Differences of length between device measurements and observer measurements of the 6-minute walk test (6MWT)
Measured: 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)]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Reassessing study feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, Ospedale San Bortolo di Vicenza, Azienda Ospedaliera di Padova
- Responsible party
- Sponsor
- Investigators
- Giuseppe Tarantini, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843320
- Sponsor's protocol ID
- CAPABILITY
- Acronym
- CAPABILITY
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2019
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 16980116van 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.
PubMed 23229811Stortecky 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.
PubMed 22917726Lorenzoni 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.
PubMed 33180023
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study
- ClinicalTrials.gov ID
- NCT03843320
- Acronym / sponsor ID
- CAPABILITY / CAPABILITY
- Conditions
- Aortic Valve Stenosis
- Keywords
- SAVR, TAVR, Physical function, Aortic valve replacement, Wearable devices, Smart watch, Activity tracker
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Reassessing study feasibility
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, Ospedale San Bortolo di Vicenza, Azienda Ospedaliera di Padova
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAVR | – | Device: INSPIRIS RESILIA, Device: EDWARDS INTUITY, Device: Carpentier-Edwards PERIMOUNT Magna-EasePatients 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. |
| TAVR | – | Device: SAPIEN 3, Device: SAPIEN XTPatients 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. |
Who may qualify
- Ages
- 75 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing TAVR or SAVR
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAPIEN 3Transcatheter aortic valve replacement | Device | TAVR |
| SAPIEN XTTranscatheter aortic valve replacement | Device | TAVR |
| INSPIRIS RESILIASurgical aortic valve replacement | Device | SAVR |
| EDWARDS INTUITYSurgical aortic valve replacement | Device | SAVR |
| Carpentier-Edwards PERIMOUNT Magna-EaseSurgical aortic valve replacement | Device | SAVR |
Primary outcome
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.
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.
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.
6 secondary outcomes
validity of the device in measuring physical function
Time frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
patients' compliance with the device
Time frame: 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)
Time frame: 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)
Time frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
Sleep quality assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
Cognitive function assessed by the Mini Mental State Examination (MMSE)
Time frame: 1, 3, 6 and 12 months after treatment with TAVR/SAVR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 16980116Nkomo 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.
- Background: PubMed 23229811van 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.
- Background: PubMed 22917726Stortecky 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.
- Derived from this study: PubMed 33180023Lorenzoni 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.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Tarantini, MD principal investigator
University of Padova
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by University of Padova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6 MWT) at 1 month (time frame: 1 month after treatment with TAVR/SAVR). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843320, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.