Aortic StenosisNCT07035847
Transaxillary TAVR With Solely Echocardiography Guidance
A study testing Echocardiography guided TAVR in people with Aortic Stenosis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Echocardiography guided TAVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2026
- 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
- symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2)
- suitable for Transaxillary TAVR
Who cannot join
- required hybrid procedures or concomitant interventions on other cardiac malformations
- inoperable due to extremely high surgical risk or severe comorbidities
- untreated clinically significant (>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
- previously undergone aortic valve replacement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xu Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiangbin Pan, 088396666, panxiangbin@fuwaihospital.org
About this study
Official title: Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
- Conditions
- Aortic Stenosis
- Being tested
- Echocardiography guided TAVR
- 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.
Echocardiography guided TAVRProcedure or surgery
Echocardiography guided TAVR
| Study group | Role | What they receive |
|---|---|---|
| Echo guided TAVR | Experimental | Patients received Echocardiography guided TAVR Receives: Procedure: Echocardiography guided TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve Academic Research Consortium-3
Outcomes were reported according to the VARC-3 criteria.Which include: Technical success: Evaluated immediately post-procedure (e.g., successful vascular access, device delivery, deployment, no immediate complications).
Device success: Includes successful valve function with acceptable hemodynamics and positioning.
Procedural success: Includes 30-day outcomes, combining technical/device success and absence of major complications.
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalXu Wang, MD, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035847
- Sponsor's protocol ID
- 2025-0501
- Status last verified
- Feb 2026
- First submitted
- 11 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance
- ClinicalTrials.gov ID
- NCT07035847
- Acronym / sponsor ID
- 2025-0501
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echo guided TAVR | Experimental | Procedure: Echocardiography guided TAVRPatients received Echocardiography guided TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2)
- suitable for Transaxillary TAVR
Key exclusion criteria (4 listed)
- required hybrid procedures or concomitant interventions on other cardiac malformations
- inoperable due to extremely high surgical risk or severe comorbidities
- untreated clinically significant (>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
- previously undergone aortic valve replacement.
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 |
|---|---|---|
| Echocardiography guided TAVREchocardiography guided TAVR | Procedure or surgery | Echo guided TAVR |
Primary outcome
Valve Academic Research Consortium-3
Time frame: 30 days after intervention
Outcomes were reported according to the VARC-3 criteria.Which include: Technical success: Evaluated immediately post-procedure (e.g., successful vascular access, device delivery, deployment, no immediate complications). Device success: Includes successful valve function with acceptable hemodynamics and positioning. Procedural success: Includes 30-day outcomes, combining technical/device success and absence of major complications.
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xu Wang, MD contact
Xiangbin Pan, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Xu Wang, MD study director
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography guided TAVR in people with Aortic Stenosis, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 2 inclusion and 4 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 27 Feb 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. 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 Xiangbin Pan, MD (+8688396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve Academic Research Consortium-3 (time frame: 30 days after intervention). 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 27 Feb 2026.