Aortic Valve StenosisNCT04414865
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
An observational study of Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 2 sites in China.
Trial summary
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- VitaFlow™ Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 26 Apr 2020to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team
Who may be able to join
- Age≥70 years;
- Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area<0.8cm² (or EOA index<0.5cm²/m²);
- The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
- The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Who cannot join
- Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- Vascular diseases or anatomical condition preventing the device access；
- Previous implantation of mechanical or bioprosthesis valve in the aortic position；
- Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
- Ongoing sepsis, including active endocarditis；
- Estimated Life expectancy< 12 months；
- Participating in another trial and the primary endpoint is not achieved.
- Inability to comply with the clinical investigation follow-up or other requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Ruijing Hospital，Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Ruiyan Zhang, Prof, 13601911729, zhangruiyan@263.net
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality
Daxin Zhou, Prof, 13801641512, zhou.daxin@zs-hospital.sh.cn
About this study
Official title: A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
Read the detailed description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
- Conditions
- Aortic Valve Stenosis
- Being tested
- VitaFlow™ Transcatheter Aortic 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.
VitaFlow™ Transcatheter Aortic Valve SystemDevice
VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
| Study group | Role | What they receive |
|---|---|---|
| single arm, treatment group | Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System Receives: Device: VitaFlow™ Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality at 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Measured: 12 months post implantation
Secondary outcomes (9)
Valve function-mean transvalvular gradient
Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Measured: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Valve function-effective orifice area
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
Measured: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Valve function-degree of prosthetic valve regurgitation
Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Measured: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Rate of safety events according to VARC2
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation
Measured: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of other TAVI-related complications
Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)
Measured: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of device success
Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function
Measured: at immediate post implantation
Rate of balloon pre-dilatation success
Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter
Measured: at immediate post implantation
Rate of balloon post-dilatation success
Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter
Measured: at immediate post implantation
Rate of procedure success
Rate of procedure success, assessed by the device success and peri-procedural complications
Measured: at immediate post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start26 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414865
- Sponsor's protocol ID
- LAUNCH-2020
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04414865
- Acronym / sponsor ID
- LAUNCH-2020
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Jun 2020 (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 study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
Detailed description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, treatment group | – | Device: VitaFlow™ Transcatheter Aortic Valve SystemSubjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team
Key inclusion criteria (4 listed)
- Age≥70 years;
- Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area<0.8cm² (or EOA index<0.5cm²/m²);
- The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
- The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Key exclusion criteria (8 listed)
- Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- Vascular diseases or anatomical condition preventing the device access；
- Previous implantation of mechanical or bioprosthesis valve in the aortic position；
- Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
- Ongoing sepsis, including active endocarditis；
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 |
|---|---|---|
| VitaFlow™ Transcatheter Aortic Valve SystemVitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set | Device | single arm, treatment group |
Primary outcome
Rate of all-cause mortality at 12 months post implantation
Time frame: 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
9 secondary outcomes
Valve function-mean transvalvular gradient
Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Valve function-effective orifice area
Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Valve function-degree of prosthetic valve regurgitation
Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
Rate of safety events according to VARC2
Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of other TAVI-related complications
Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of device success
Time frame: at immediate post implantation
Rate of balloon pre-dilatation success
Time frame: at immediate post implantation
Rate of balloon post-dilatation success
Time frame: at immediate post implantation
Rate of procedure success
Time frame: at immediate post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhujun Cai, PhD ((86)(21)38954600, zjcai@micoport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality at 12 months post implantation (time frame: 12 months post implantation). 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 Jun 2020.