Aortic RegurgitationNCT07458672
TAVR for Aortic Regurgitation Under TTE Guidance
A study testing TTE guided TAVR in people with Aortic Regurgitation and Transcatheter Aortic Valve Replacement (TAVR), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- TTE guided TAVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Severe native aortic regurgitation (AR) confirmed by echocardiography (per guideline-recommended multiparametric assessment).
- Indication for intervention, defined as symptomatic severe AR (e.g., NYHA class II-IV) or asymptomatic severe AR with evidence of LV decompensation (e.g., reduced LVEF and/or LV dilation per guideline thresholds).
- Deemed appropriate for transfemoral TAVR by a multidisciplinary Heart Team (e.g., elevated/prohibitive surgical risk or other clinical/anatomic factors favoring transcatheter therapy).
Who cannot join
- Active infective endocarditis or ongoing systemic infection/sepsis.
- Aortic pathology requiring open surgery, such as significant ascending aortic aneurysm/root disease above surgical thresholds, acute aortic syndrome, or other conditions where surgery is mandated.
- Annulus/landing-zone dimensions outside device range
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance
Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or other contraindications. In patients with native aortic regurgitation, the absence of annular/leaflet calcification and frequent annular dilation can further complicate device positioning and anchoring, increasing the procedural dependence on precise imaging guidance. Transthoracic echocardiography (TTE) provides real-time assessment of valve anatomy, coaxial alignment, depth control, and immediate hemodynamic results, and-when used as the primary imaging modality-offers a potential "radiation- and contrast-free" alternative for selected patients. However, clinical evidence for fully TTE-guided (echo-only) TAVR remains limited. Here, the investigators describe our procedural workflow and evaluate the feasibility and early outcomes of total TTE-guided TAVR for treating aortic regurgitation.
- Being tested
- TTE guided TAVR
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTE guided TAVRProcedure or surgery
Intraprocedural TTE will be used to assess valve position and function, transvalvular gradients, paravalvular leak, and pericardial effusion, and to direct any adjunctive maneuvers (e.g., repositioning, post-dilation, or second-valve implantation) as clinically indicated. Peri-procedural anticoagulation, anesthesia strategy, and post-procedure medical therapy will follow institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| TTE Guided TAVR | Experimental | Participants assigned to this arm will undergo total transthoracic echocardiography (TTE)-guided transcatheter aortic valve replacement (TAVR) for treatment of significant native aortic regurgitation. The procedure will be performed using a commercially available transcatheter heart valve and standard delivery system, with procedural planning and all key steps and immediate post-deployment evaluation-guided primarily by real-time TTE without routine fluoroscopy or iodinated contrast. Receives: Procedure: TTE guided TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Early Safety
30-day Early Safety (composite, VARC-3): occurrence of any of the following within 30 days:
All-cause mortality Disabling stroke Life-threatening or major bleeding Major vascular complication Acute kidney injury stage 2-3 (or new dialysis) Coronary obstruction requiring intervention Valve-related dysfunction or malposition requiring repeat intervention (e.g., second valve, surgical conversion)
Measured: 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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 RegurgitationStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458672
- Sponsor's protocol ID
- 20260302
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance
- ClinicalTrials.gov ID
- NCT07458672
- Acronym / sponsor ID
- 20260302
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 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.
Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or other contraindications. In patients with native aortic regurgitation, the absence of annular/leaflet calcification and frequent annular dilation can further complicate device positioning and anchoring, increasing the procedural dependence on precise imaging guidance. Transthoracic echocardiography (TTE) provides real-time assessment of valve anatomy, coaxial alignment, depth control, and immediate hemodynamic results, and-when used as the primary imaging modality-offers a potential "radiation- and contrast-free" alternative for selected patients. However, clinical evidence for fully TTE-guided (echo-only) TAVR remains limited. Here, the investigators describe our procedural workflow and evaluate the feasibility and early outcomes of total TTE-guided TAVR for treating aortic regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTE Guided TAVR | Experimental | Procedure: TTE guided TAVRParticipants assigned to this arm will undergo total transthoracic echocardiography (TTE)-guided transcatheter aortic valve replacement (TAVR) for treatment of significant native aortic regurgitation. The procedure will be performed using a commercially available transcatheter heart valve and standard delivery system, with procedural planning and all key steps and immediate post-deployment evaluation-guided primarily by real-time TTE without routine fluoroscopy or iodinated contrast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Severe native aortic regurgitation (AR) confirmed by echocardiography (per guideline-recommended multiparametric assessment).
- Indication for intervention, defined as symptomatic severe AR (e.g., NYHA class II-IV) or asymptomatic severe AR with evidence of LV decompensation (e.g., reduced LVEF and/or LV dilation per guideline thresholds).
- Deemed appropriate for transfemoral TAVR by a multidisciplinary Heart Team (e.g., elevated/prohibitive surgical risk or other clinical/anatomic factors favoring transcatheter therapy).
Key exclusion criteria (3 listed)
- Active infective endocarditis or ongoing systemic infection/sepsis.
- Aortic pathology requiring open surgery, such as significant ascending aortic aneurysm/root disease above surgical thresholds, acute aortic syndrome, or other conditions where surgery is mandated.
- Annulus/landing-zone dimensions outside device range
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 |
|---|---|---|
| TTE guided TAVRIntraprocedural TTE will be used to assess valve position and function, transvalvular gradients, paravalvular leak, and pericardial effusion, and to direct any adjunctive maneuvers (e.g., repositioning, post-dilation, or second-valve implantation) as clinically indicated. Peri-procedural anticoagulation, anesthesia strategy, and post-procedure medical therapy will follow institutional standards. | Procedure or surgery | TTE Guided TAVR |
Primary outcome
30-day Early Safety
Time frame: 30-day follow-up
30-day Early Safety (composite, VARC-3): occurrence of any of the following within 30 days: All-cause mortality Disabling stroke Life-threatening or major bleeding Major vascular complication Acute kidney injury stage 2-3 (or new dialysis) Coronary obstruction requiring intervention Valve-related dysfunction or malposition requiring repeat intervention (e.g., second valve, surgical conversion)
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 9 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing TTE guided TAVR in people with Aortic Regurgitation and Transcatheter Aortic Valve Replacement (TAVR), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 3 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (+86 88396655, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Early Safety (time frame: 30-day follow-up). 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 9 Mar 2026.