Aortic Valve StenosisPhase 3STARTNCT02541877
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
A Phase 3 study testing Down sizing valve in type-0 BAS, Standard sizing valve in type-0 BAS and Standard sizing valve in TAS in people with Aortic Valve Stenosis, run by Jian'an Wang,MD,PhD at 1 site in China.
Trial summary
To observe the clinical outcomes of the different valve sizing strategies treating type-0 Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic Stenosis(TAS). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Down sizing valve in type-0 BAS, Standard sizing valve in type-0 BAS and Standard sizing valve in TAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2023
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- Patients are technical and anatomical eligible for interventions
Who cannot join
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- Aspirin
- Heparin (HIT/HITTS) and bivalirudin
- Nitinol (titanium or nickel)
- Ticlopidine and clopidogrel
- Contrast media
Show all 10Show fewer
- Subject refuses a blood transfusion.
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
- Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.
- Life expectancy is less than one year
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310009
Xianbao Liu, MD, +86-13857173887, liuxb2009@hotmail.com
Jian-an Wang, MD,PhD
About this study
Official title: A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve
To observe the clinical outcomes of the different valve sizing strategies treating type-0 Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic Stenosis(TAS).
Read the detailed description
BACKGROUND: From our current clinical experience, investigators mostly choose the smaller self-expandable transcatheter valve for type-0 BAS than that for TAS, combined with "balloon sizing" strategy. But no prospective and randomized studies show the rationality and clinical outcomes of different sizing strategies of type-0 BAS with self-expandable transcatheter valve.
AIM: To observe the clinical outcomes of the different valve sizing strategies treating type-0 BAS with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal TAS.
POPULATION: All patients with severe degenerative aortic valve stenosis referred for aortic valve intervention will be screened for study eligibility. To be included subjects must be 65 years or older, anatomical and technical eligible for both interventions, expected to survive more than 1 year after the intervention, and able to provide written informed consent. Study exclusion criteria include isolated aortic valve regurgitation or other significant valve disease, unstable preoperative condition.
DESIGN: The project is a multicenter randomized clinical trial. Patients of type-0 BAS fulfilling all inclusion and no exclusion criteria will be randomized into either Down sizing group or Standard sizing group. Randomization will be 1:1 with 53 subjects in each group. Meanwhile patients of TAS fulfilling all inclusion and no exclusion criteria will be included as a Standard group in this study. Screening and inclusion will commence in September 2015. Inclusion is expected to last 3 years, and subjects will be followed for 5 years.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Down sizing valve in type-0 BAS, Standard sizing valve in type-0 BAS, Standard sizing valve in TAS
- 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.
Down sizing valve in type-0 BASDevice
Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Down sizing valve implantation will be used in type-0 BAS.
Standard sizing valve in type-0 BASDevice
Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in type-0 BAS.
Standard sizing valve in TASDevice
Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in TAS.
| Study group | Role | What they receive |
|---|---|---|
| Down sizing valve in type-0 BAS | Experimental | Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS Receives: Device: Down sizing valve in type-0 BAS |
| Standard sizing valve in type-0 BAS | Active comparator | Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS Receives: Device: Standard sizing valve in type-0 BAS |
| Standard sizing valve in TAS | Active comparator | Standard Sizing Transcatheter Self-expandable Valve in TAS Receives: Device: Standard sizing valve in TAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Device success
- Absence of procedural mortality
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Measured: At 24 hours after procedure
Changes of prosthetic valve functions
- Valve hemodynamics
- Peri-valvular regurgitation
- Valve malpositioning
- Valve morphology
Measured: From 24 hours after procedure to 5 years
Secondary outcomes (5)
All-cause mortality and all stroke (disabling and non-disabling)
Measured: 5 years
Number of patients with procedural complications
Measured: Within first 30 days
Changes of ascending aortic diameter
Measured: Changes of baseline ascending aortic diameter at 5 years
Functional status (NYHA-classification)
Measured: 5 years
Quality of Life (SF-12)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian'an Wang,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian'an Wang,MD,PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Jian-an Wang, MD,PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541877
- Sponsor's protocol ID
- SAHZJU CT004
- Acronym
- START
- Status last verified
- Sep 2015
- First submitted
- 14 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve
- ClinicalTrials.gov ID
- NCT02541877
- Acronym / sponsor ID
- START / SAHZJU CT004
- Conditions
- Aortic Valve Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Jian'an Wang,MD,PhDUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Sep 2015 (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.
To observe the clinical outcomes of the different valve sizing strategies treating type-0 Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic Stenosis(TAS).
Detailed description
BACKGROUND: From our current clinical experience, investigators mostly choose the smaller self-expandable transcatheter valve for type-0 BAS than that for TAS, combined with "balloon sizing" strategy. But no prospective and randomized studies show the rationality and clinical outcomes of different sizing strategies of type-0 BAS with self-expandable transcatheter valve.
AIM: To observe the clinical outcomes of the different valve sizing strategies treating type-0 BAS with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal TAS.
POPULATION: All patients with severe degenerative aortic valve stenosis referred for aortic valve intervention will be screened for study eligibility. To be included subjects must be 65 years or older, anatomical and technical eligible for both interventions, expected to survive more than 1 year after the intervention, and able to provide written informed consent. Study exclusion criteria include isolated aortic valve regurgitation or other significant valve disease, unstable preoperative condition.
DESIGN: The project is a multicenter randomized clinical trial. Patients of type-0 BAS fulfilling all inclusion and no exclusion criteria will be randomized into either Down sizing group or Standard sizing group. Randomization will be 1:1 with 53 subjects in each group. Meanwhile patients of TAS fulfilling all inclusion and no exclusion criteria will be included as a Standard group in this study. Screening and inclusion will commence in September 2015. Inclusion is expected to last 3 years, and subjects will be followed for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Down sizing valve in type-0 BAS | Experimental | Device: Down sizing valve in type-0 BASDown Sizing Transcatheter Self-expandable Valve in Type-0 BAS |
| Standard sizing valve in type-0 BAS | Active comparator | Device: Standard sizing valve in type-0 BASStandard Sizing Transcatheter Self-expandable Valve in Type-0 BAS |
| Standard sizing valve in TAS | Active comparator | Device: Standard sizing valve in TASStandard Sizing Transcatheter Self-expandable Valve in TAS |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- Patients are technical and anatomical eligible for interventions
Key exclusion criteria (10 listed)
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- Subject refuses a blood transfusion.
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
- Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.
- Life expectancy is less than one year
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 |
|---|---|---|
| Down sizing valve in type-0 BASSubjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Down sizing valve implantation will be used in type-0 BAS. | Device | Down sizing valve in type-0 BAS |
| Standard sizing valve in type-0 BASSubjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in type-0 BAS. | Device | Standard sizing valve in type-0 BAS |
| Standard sizing valve in TASSubjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in TAS. | Device | Standard sizing valve in TAS |
Primary outcome
Number of participants with Device success
Time frame: At 24 hours after procedure
1. Absence of procedural mortality 2. Correct positioning of a single prosthetic heart valve into the proper anatomical location 3. Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Changes of prosthetic valve functions
Time frame: From 24 hours after procedure to 5 years
1. Valve hemodynamics 2. Peri-valvular regurgitation 3. Valve malpositioning 4. Valve morphology
5 secondary outcomes
All-cause mortality and all stroke (disabling and non-disabling)
Time frame: 5 years
Number of patients with procedural complications
Time frame: Within first 30 days
Changes of ascending aortic diameter
Time frame: Changes of baseline ascending aortic diameter at 5 years
Functional status (NYHA-classification)
Time frame: 5 years
Quality of Life (SF-12)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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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.
Jian-an Wang, MD,PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Down sizing valve in type-0 BAS, Standard sizing valve in type-0 BAS and Standard sizing valve in TAS in people with Aortic Valve Stenosis, run by Jian'an Wang,MD,PhD at 1 site in China.
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 4 inclusion and 10 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 4 Sep 2015. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xianbao Liu, MD (+86-13857173887, liuxb2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Device success (time frame: At 24 hours after 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 4 Sep 2015.