Aortic Valve Stenosis3MTAVRNCT02287662
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
A study testing Vancouver 3M Clinical Pathway in people with Aortic Valve Stenosis, run by BC Centre for Improved Cardiovascular Health at 1 site in Canada.
Trial summary
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Vancouver 3M Clinical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to May 2018
- 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 balloon expandable 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
- Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
- Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
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- Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
- MMSE < 24/30 (unless language barrier or limited formal education), 5-metre gait > 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL < 6/6
- Insufficient social support to facilitate next day discharge
- Airway unfavourable for emergent intubation
- Inability to lay supine without conscious sedation or general anesthetic
- Not receiving a balloon expandable transcatheter heart valve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M TAVR Study
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Vancouver 3M 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 3M Clinical PathwayOther
| Study group | Role | What they receive |
|---|---|---|
| Vancouver 3M Clinical Pathway | Experimental | The Vancouver 3M 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 3M 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 3M Clinical Pathway, who are discharged the next day
Measured: Next day
Secondary outcomes (14)
All-cause mortality
Measured: 30 days post-procedure
Stroke
Measured: 30 days post-procedure
30-day major vascular complications
Measured: 30 days post-procedure
30-day major/life-threatening bleed
Measured: 30 days post-procedure
Any readmission to hospital within 30 days
Measured: 30 days post-procedure
> mild paravalvular regurgitation
Measured: Post-procedure/discharge
New permanent pacemaker
Measured: 30 days post-procedure
Conversion to general anesthetic/intubation
Measured: Peri-procedure
Myocardial infarction
Measured: Peri-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 and SF-12 at baseline, 2 weeks, 30 days, and 1 year
Measured: Baseline, and 2 weeks, 30 day and 1 year post procedure
Economic evaluation including health resource utilization, and cost effectiveness
Measured: Peri- and post-procedure
Death or stroke at one year
Measured: 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 posted11 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 411 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
- NCT02287662
- Acronym
- 3MTAVR
- Status last verified
- Jul 2018
- First submitted
- 6 Nov 2014
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Butala NM, Wood DA, Li H, Chinnakondepalli K, Lauck SB, Sathananthan J, Cairns JA, Magnuson EA, Barker M, Webb JG, Welsh R, Cheung A, Ye J, Velianou JL, Wijeysundera HC, Asgar A, Kodali S, Thourani VH, Cohen DJ; 3M-TAVR Investigators. Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Circ Cardiovasc Interv. 2022 Oct;15(10):e012168. doi: 10.1161/CIRCINTERVENTIONS.122.012168. Epub 2022 Oct 18.
PubMed 36256698
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M TAVR Study
- ClinicalTrials.gov ID
- NCT02287662
- Acronym / sponsor ID
- 3MTAVR
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (estimated)
- Lead sponsor
- BC Centre for Improved Cardiovascular HealthUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancouver 3M Clinical Pathway | Experimental | Other: Vancouver 3M Clinical PathwayThe Vancouver 3M 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 balloon expandable transcatheter heart valve
- Considered at increased surgical risk by the Multidisciplinary Heart Team.
- Informed written consent
Key exclusion criteria (12 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
- Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-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 3M Clinical Pathway | Other | Vancouver 3M 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 3M Clinical Pathway, who are discharged the next day
Time frame: Next day
14 secondary outcomes
All-cause mortality
Time frame: 30 days post-procedure
Stroke
Time frame: 30 days post-procedure
30-day major vascular complications
Time frame: 30 days post-procedure
30-day major/life-threatening bleed
Time frame: 30 days post-procedure
Any readmission to hospital within 30 days
Time frame: 30 days post-procedure
> mild paravalvular regurgitation
Time frame: Post-procedure/discharge
New permanent pacemaker
Time frame: 30 days post-procedure
Conversion to general anesthetic/intubation
Time frame: Peri-procedure
Myocardial infarction
Time frame: Peri-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 and SF-12 at baseline, 2 weeks, 30 days, and 1 year
Time frame: Baseline, and 2 weeks, 30 day and 1 year post procedure
Economic evaluation including health resource utilization, and cost effectiveness
Time frame: Peri- and post-procedure
Death or stroke at one year
Time frame: 1 year post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 36256698Butala NM, Wood DA, Li H, Chinnakondepalli K, Lauck SB, Sathananthan J, Cairns JA, Magnuson EA, Barker M, Webb JG, Welsh R, Cheung A, Ye J, Velianou JL, Wijeysundera HC, Asgar A, Kodali S, Thourani VH, Cohen DJ; 3M-TAVR Investigators. Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Circ Cardiovasc Interv. 2022 Oct;15(10):e012168. doi: 10.1161/CIRCINTERVENTIONS.122.012168. Epub 2022 Oct 18.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancouver 3M Clinical Pathway in people with Aortic Valve Stenosis, run by BC Centre for Improved Cardiovascular Health at 1 site in Canada.
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 12 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: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT02287662, which also lists 1 linked publication.
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 6 Jul 2018.