Impact of SAVR and TAVR on Patient's Activity and Mobility
Key facts
- Who runs it
- University of Padova
- Where
- Italy2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- People taking part
- 340 people, planned
- Started
- Dec 2021
- Ended
- Dec 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- SAPIEN 3
- SAPIEN XT
- INSPIRIS RESILIA
- EDWARDS INTUITY
- Carpentier-Edwards PERIMOUNT Magna-Ease
- Record updated
- 3 December 2020
- Why it stopped
- Reassessing study feasibility
Who can take part
- Age
- 75 years to 89 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- Dyskinesia or Parkinson's disease
- Use of walking aids
- Reduced survival expectancy due to severe co-morbidities (<1 year)
- Lack of any of inclusion criteria
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
The 2 groups in the trial
- 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.
Treatment: INSPIRIS RESILIA, EDWARDS INTUITY, and 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.
Treatment: SAPIEN 3 and SAPIEN XT
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study
- Publications
- Record updated
- 3 December 2020