Aortic Valve StenosisSAFETAVRNCT03600935
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
A study testing Vancouver Clinical Pathway in people with Aortic Valve Stenosis, run by BC Centre for Improved Cardiovascular Health.
Trial summary
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Vancouver Clinical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Sep 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
- Considered at increased surgical risk by the Multidisciplinary Heart Team
- Informed written consent
Who cannot join
- Non-cardiovascular co-morbidity reducing life expectancy to <3 years
- Any factor precluding 1 year follow-up
- Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
- Predicted inability to perform uncomplicated percutaneous vascular access and closure
- Illiofemoral diameter <6 mm (for 23 and 25 mm valves) and <6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
- Surgical prosthesis <23 mm (labelled size) for valve-in-valve procedure
Show all 11Show fewer
- In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
- Language barriers (inability to understand peri-procedural and discharge instructions)
- Insufficient social support post procedure to allow next day discharge
- Airway unfavourable for emergent intubation
- Inability to lay supine without conscious sedation or general anaesthetic
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Vancouver Clinical Pathway
- Keywords
- Transcatheter Aortic Valve Replacement
- 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.
Vancouver Clinical PathwayOther
Vancouver Clinical Pathway
| Study group | Role | What they receive |
|---|---|---|
| Vancouver Clinical Pathway | Experimental | The Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate. Receives: Other: Vancouver Clinical Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause mortality or stroke
Measured: 30 days post-procedure
The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day
Measured: Discharge 1 day after procedure
Secondary outcomes (12)
All-cause mortality
Measured: 30 days post-procedure
Stroke
Measured: 30 days post-procedure
Major vascular complications
Measured: 30 days post-procedure
Major/Life-threatening bleed
Measured: 30 days post-procedure
Any hospital readmission
Measured: 30 days post-procedure
>mild paravalvular regurgiation
Measured: Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
New permanent pacemaker
Measured: 30 days post-procedure
Patient is converted from local to general anaesthetic/receives intubation during procedure
Measured: This happens during the procedure
Myocardial infarction
Measured: This happens during the procedure
Repeat procedure for valve-related dysfunction
Measured: 30 days post-procedure
Stage 3 acute kidney injury (need for dialysis)
Measured: 30 days post-procedure
Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year
Measured: Baseline, and 30 days and 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startOct 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BC Centre for Improved Cardiovascular Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- David A Wood, MD, Principal investigator, University of British ColumbiaJohn A Webb, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600935
- Sponsor's protocol ID
- TBD1
- Acronym
- SAFETAVR
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
- ClinicalTrials.gov ID
- NCT03600935
- Acronym / sponsor ID
- SAFETAVR / TBD1
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- BC Centre for Improved Cardiovascular HealthUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Oct 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 Jul 2018 (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.
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancouver Clinical Pathway | Experimental | Other: Vancouver Clinical PathwayThe Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
- Considered at increased surgical risk by the Multidisciplinary Heart Team
- Informed written consent
Key exclusion criteria (11 listed)
- Non-cardiovascular co-morbidity reducing life expectancy to <3 years
- Any factor precluding 1 year follow-up
- Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
- Predicted inability to perform uncomplicated percutaneous vascular access and closure
- Illiofemoral diameter <6 mm (for 23 and 25 mm valves) and <6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
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 |
|---|---|---|
| Vancouver Clinical PathwayVancouver Clinical Pathway | Other | Vancouver Clinical Pathway |
Primary outcome
The composite of all-cause mortality or stroke
Time frame: 30 days post-procedure
The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day
Time frame: Discharge 1 day after procedure
12 secondary outcomes
All-cause mortality
Time frame: 30 days post-procedure
Stroke
Time frame: 30 days post-procedure
Major vascular complications
Time frame: 30 days post-procedure
Major/Life-threatening bleed
Time frame: 30 days post-procedure
Any hospital readmission
Time frame: 30 days post-procedure
>mild paravalvular regurgiation
Time frame: Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
New permanent pacemaker
Time frame: 30 days post-procedure
Patient is converted from local to general anaesthetic/receives intubation during procedure
Time frame: This happens during the procedure
Myocardial infarction
Time frame: This happens during the procedure
Repeat procedure for valve-related dysfunction
Time frame: 30 days post-procedure
Stage 3 acute kidney injury (need for dialysis)
Time frame: 30 days post-procedure
Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year
Time frame: Baseline, and 30 days and 1 year post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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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.
David A Wood, MD principal investigator
University of British Columbia
John A Webb, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Vancouver Clinical Pathway in people with Aortic Valve Stenosis, run by BC Centre for Improved Cardiovascular Health.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact David A Wood, MD (6048755601, david.wood@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of all-cause mortality or stroke (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2018.