Valve Disease, AorticArc-FITNCT07320274
ArcFlex Sheath in TAVR Trial
A study testing ArcFlex Sheath and ordinary sheath in people with Valve Disease, Aortic, run by Sun Yat-sen University at 1 site in China.
Trial summary
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valve Disease, Aortic
- What is being tested?
- ArcFlex Sheath and ordinary sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Mar 2030
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Judged by a professional cardiologist to require TAVR surgery
- NYHA ≥ II grade
- Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route
- Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.
Who cannot join
- Presence of other valvular diseases requiring concurrent intervention.
- Anatomical characteristics unsuitable for transcatheter valve implantation.
- Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.
- Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy >1.5 cm).
- Acute myocardial infarction within the past 30 days.
- Intracardiac mass, thrombus, or vegetation indicated by echocardiography.
Show all 16Show fewer
- Active infective endocarditis or any other active infection.
- Intolerance to tolerate anticoagulant or antiplatelet therapy.
- Coagulopathy or refusal to receive blood transfusion therapy.
- Known allergy to device materials or contrast agents.
- Acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
- Stroke or transient ischemic attack (TIA) within the past 3 months.
- Requirement for emergency surgical treatment for any reason.
- Expected life expectancy of less than 12 months due to non-cardiac causes.
- Severe disabling dementia or inability to perform activities of daily living.
- Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
xiaodong zhuang, MD, 020-89998001, zhuangxd3@mail.sysu.edu.cn
About this study
Official title: ArcFlex Sheath in TAVR Trial(Arc-FIT)
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
- Conditions
- Valve Disease, Aortic
- Being tested
- ArcFlex Sheath, ordinary sheath
- Keywords
- TAVR, Sheath, ArcFlex
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcFlex SheathDevice
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
ordinary sheathDevice
ordinary sheath
| Study group | Role | What they receive |
|---|---|---|
| ArcFlex Sheath | Experimental | ArcFlex Sheath Receives: Device: ArcFlex Sheath |
| control group | Placebo comparator | The ordinary sheath Receives: Device: ordinary sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical instruments
The success rate of immediate surgical instruments
Measured: 24 hours
Secondary outcomes (2)
30-day mortality rate
30-day mortality rate
Measured: 30days
One-year mortality rate
One-year mortality rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
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 Valve Disease, AorticStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320274
- Sponsor's protocol ID
- Arc-FIT trial
- Acronym
- Arc-FIT
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhu G, Yang T, Zhang G, Xu K, Shang X, Zhao Y, Ni B, Li H, Tang M, Jian Z, Yang Y, Zhang H, Wei L, Liu J, Noterdaeme T, Lange R, Guo Y, Pan X, Wu Y, Yang J. Clinical value of aortic arch morphology in transfemoral TAVR: artificial intelligence evaluation. Int J Surg. 2025 Mar 1;111(3):2338-2347. doi: 10.1097/JS9.0000000000002232.
PubMed 39869394
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArcFlex Sheath in TAVR Trial(Arc-FIT)
- ClinicalTrials.gov ID
- NCT07320274
- Acronym / sponsor ID
- Arc-FIT / Arc-FIT trial
- Conditions
- Valve Disease, Aortic
- Keywords
- TAVR, Sheath, ArcFlex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 6 Jan 2026 (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.
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArcFlex Sheath | Experimental | Device: ArcFlex SheathArcFlex Sheath |
| control group | Placebo comparator | Device: ordinary sheathThe ordinary sheath |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Judged by a professional cardiologist to require TAVR surgery
- NYHA ≥ II grade
- Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route
- Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.
Key exclusion criteria (16 listed)
- Presence of other valvular diseases requiring concurrent intervention.
- Anatomical characteristics unsuitable for transcatheter valve implantation.
- Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.
- Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy >1.5 cm).
- Acute myocardial infarction within the past 30 days.
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 |
|---|---|---|
| ArcFlex SheathTAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure. | Device | ArcFlex Sheath |
| ordinary sheathordinary sheath | Device | control group |
Primary outcome
surgical instruments
Time frame: 24 hours
The success rate of immediate surgical instruments
2 secondary outcomes
30-day mortality rate
Time frame: 30days
One-year mortality rate
Time frame: 1 year
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 6 Jan 2026.
- Results publication: PubMed 39869394Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhu G, Yang T, Zhang G, Xu K, Shang X, Zhao Y, Ni B, Li H, Tang M, Jian Z, Yang Y, Zhang H, Wei L, Liu J, Noterdaeme T, Lange R, Guo Y, Pan X, Wu Y, Yang J. Clinical value of aortic arch morphology in transfemoral TAVR: artificial intelligence evaluation. Int J Surg. 2025 Mar 1;111(3):2338-2347. doi: 10.1097/JS9.0000000000002232.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArcFlex Sheath and ordinary sheath in people with Valve Disease, Aortic, run by Sun Yat-sen University 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 16 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: opening soon, as of the sponsor's last update on 6 Jan 2026. 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. Some participants in this study may receive a placebo. 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 Xiaodong zhuang, MD (020-89998001, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical instruments (time frame: 24 hours). 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 NCT07320274, 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 Jan 2026.