Aortic Valve StenosisPhase 3LOTUS-CHINANCT02536703
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
A Phase 3 study testing Lotus Valve System in people with Aortic Valve Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis. 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?
- Lotus Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2020
- 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
- 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
About this study
Official title: LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Lotus Valve System
- 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.
Lotus Valve SystemDevice
Lotus Valve System
| Study group | Role | What they receive |
|---|---|---|
| Lotus Valve System | Experimental | Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System Receives: Device: Lotus Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined rate of death from any cause, myocardial infarction, and stroke
Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
Measured: 30 days following procedure
Secondary outcomes (4)
Number of participants with procedural complications
Measured: 30 days following procedure
Functional status (NYHA-classification)
Measured: 6 months following procedure
Echocardiographic prosthesis status
Measured: 6 months following procedure
Quality of Life (SF-12)
Measured: 6 months following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2020 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT02536703
- Sponsor's protocol ID
- SAHZJU CT005
- Acronym
- LOTUS-CHINA
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
- ClinicalTrials.gov ID
- NCT02536703
- Acronym / sponsor ID
- LOTUS-CHINA / SAHZJU CT005
- Conditions
- Aortic Valve Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 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 confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lotus Valve System | Experimental | Device: Lotus Valve SystemTranscatheter Aortic Valve Implantation (TAVI) with Lotus Valve System |
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 (6 listed)
- 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
- 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.
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 |
|---|---|---|
| Lotus Valve SystemLotus Valve System | Device | Lotus Valve System |
Primary outcome
Combined rate of death from any cause, myocardial infarction, and stroke
Time frame: 30 days following procedure
Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
4 secondary outcomes
Number of participants with procedural complications
Time frame: 30 days following procedure
Functional status (NYHA-classification)
Time frame: 6 months following procedure
Echocardiographic prosthesis status
Time frame: 6 months following procedure
Quality of Life (SF-12)
Time frame: 6 months following procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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 Lotus Valve System in people with Aortic Valve Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 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 1 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?
Combined rate of death from any cause, myocardial infarction, and stroke (time frame: 30 days following procedure). 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 1 Sep 2015.