Aortic StenosisPhase 4ECHO-TAVRNCT07317804
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）
A Phase 4 study testing Echocardiographic guidance and Fluoroscopic guidance in people with Aortic Stenosis and TAVI, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis, TAVI, TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- Echocardiographic guidance and Fluoroscopic guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2026to 31 Jul 2028
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area < 1.0 cm² or peak velocity ≥ 4.0 m/s or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area < 1.0 cm², mean transvalvular pressure difference < 40 mmHg, left ventricular ejection fraction < 50%, stroke volume index < 35 ml/m², and diagnosed as true severe aortic valve stenosis by dobutamine stress test);
- 2. Patients aged 65 years ≤ age < 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery;
- 3. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound;
- 4. The patient has signed the informed consent form and is willing to participate in this study.
Who cannot join
- 1. Imaging (ultrasound and/or CT and/or MRI) confirmed a lesion, thrombus or calculus in the left ventricle;
- 2. Severe obstruction of the left ventricular outflow tract;
- 3. Severe right ventricular dysfunction;
- 4. Acute myocardial infarction within 30 days before the procedure;
- 5. Active endocarditis history within 180 days before the procedure;
- 6. Inappropriate aortic root anatomy (such as combined aortic dissection, excessive aortic annulus, risk of coronary artery occlusion, etc.);
Show all 17Show fewer
- 7. Severe calcification and distortion of the surgical approach;
- 8. Left ventricular ejection fraction less than 20%;
- 9. Other cardiac diseases that require concurrent treatment (such as severe mitral regurgitation, atrial fibrillation, etc.);
- 10. History of stroke or transient ischemic attack within 90 days before the procedure;
- 11. Liver cirrhosis or active liver disease;
- 12. Renal insufficiency (creatinine clearance rate < 30 mL/min) and/or undergoing renal replacement therapy;
- 13. Unable to tolerate anticoagulation therapy during or after the procedure;
- 14. Participating in other drug or device research;
- 15. Any emergency or surgical operation within 30 days before the procedure;
- 16. Other severe comorbidities, even if the valve stenosis is corrected, the expected life expectancy is less than 1 year;
- 17. Other conditions deemed unsuitable for TAVR surgery by the cardiac team.
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
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Beijing, Beijing Municipality, 100037
Xiaopeng Hu, MD.PhD, +86-13621188439, 13621188439@139.com
About this study
Official title: Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise.
Transcatheter aortic valve replacement (TAVR/TAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy.
Read more
Conventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff.
Echocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary.
To address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.
- Being tested
- Echocardiographic guidance, Fluoroscopic guidance
- Keywords
- Ultrasound-guided, Percutaneous Intervention, TAVI(Transcatheter Aortic Valve Implantation), TAVI, Aortic Stenosis, PAN Procedure, non fluoroscopic
- 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.
Echocardiographic guidanceDevice
After detailed evaluation, patients randomized in this group will undergo TAVI procedure under guidance of fully echocardiography but any fluoroscopy in the entire process.
Fluoroscopic guidanceDevice
After detailed evaluation, patients randomized in this group will undergo TAVI procedure under combined guidance of echocardiography and fluoroscopy in the entire process.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography-guided group | Experimental | Patients randomized to the echocardiography-guided group will undergo a TAVI procedure under solely echo guidance. Receives: Device: Echocardiographic guidance |
| Fluoroscopy-guided intervention | Active comparator | Patients randomized to the fluoroscopy-guided group will undergo a TAVI procedure under the guidance of X-ray Receives: Device: Fluoroscopic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
Device success (at discharge，from the VARC-3 (Valve Academic Research Consortium - 3)) required the fulfillment of all of the following conditions:
- Technical success;
- No death;
- No additional surgery or intervention was required due to device-related, important vascular/pathway-related complications or cardiac structural complications related to the device (excluding permanent pacemakers);
- The valve achieved the expected performance (average transvalvular pressure difference < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and no more than moderate-grade valve intra-aneurysmal reflux or paravalvular leakage).
Measured: at the time of the participants' discharge up to 15 days after the procedure
Secondary outcomes (20)
Technique success
technique success, according to the definition of technical success in the VARC-3, must meet all of the following conditions:
- No death;
- Successful establishment of vascular access, implantation of the valve, and withdrawal from the delivery system;
- Correct placement of a single artificial heart valve in the appropriate anatomical position;
- No surgical or interventional procedures due to complications from instruments, major blood vessels or access routes, or cardiac structures.
Measured: evaluated at the time of leaving the operating room
Device success
The 30-day device success rate was evaluated according to the definition of VARC-3 for device success. This metric must meet all of the following conditions:
- Technical success;
- No death;
- No surgical or interventional procedures due to complications from the device, main blood vessels or access, or cardiac structures;
- The valve achieves the expected performance (average transvalvular pressure gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and no more than moderate valve insufficiency or paravalvular leakage).
Measured: at 30 days after the procedure
The all-cause mortality rate
The all-cause mortality rate
Measured: at 30 days, 1 year after the procedure
Cardiovascular mortality
Cardiovascular mortality rate
Measured: at 30 days, 1 year after the procedure
stroke
The incidence of stroke
Measured: at 30 days, 1 year after the procedure
vascular complications
The incidence of vascular complications
Measured: at 30 days, 1 year after the procedure
bleeding (including VARC-3 grade severe bleeding, life-threatening bleeding, and fatal bleeding)
The incidence of postoperative bleeding (including VARC-3 grade severe bleeding, life-threatening bleeding, and fatal bleeding)
Measured: at 30 days, 1 year after the procedure
acute kidney injury
The incidence of acute kidney injury
Measured: at 30 days, 1 year after the procedure
The permanent pacemaker implantation(due to new conduction abnormalities or the aggravation of existing conduction abnormalities)
The permanent pacemaker implantation rate (due to new conduction abnormalities or the aggravation of existing conduction abnormalities)
Measured: at 30 days, 1 year after the procedure
coronary artery blockages that require intervention
The incidence of coronary artery blockages that require intervention
Measured: at 30 days, 1 year after the procedure
valve stenosis or regurgitation (perivalvular and central)
echocardiography was used to assess the incidence of valve stenosis or regurgitation (perivalvular and central)
Measured: at 30 days, 1 year after the procedure
The rehospitalization due to aortic valve stenosis or surgical complications
The re-hospitalization rate due to aortic valve stenosis or surgical complications
Measured: at 30 days, 1 year after the procedure
new-onset atrial fibrillation
The incidence of new-onset atrial fibrillation
Measured: at 30 days, 1 year after the procedure
structural valve regurgitation of the bioprosthetic aortic valve (as defined by VARC-3)
The incidence of structural valve regurgitation of the bioprosthetic aortic valve (as defined by VARC-3)
Measured: at 30 days, 1 year after the procedure
Length of procedure
Length of procedure
Measured: at discharge up to 15 days after the procedure
Length of hospital stay
Length of hospital stay
Measured: at discharge up to 15 days after the procedure
fluoroscopy time
fluoroscopy time
Measured: at discharge up to 15 days after the procedure
Radiation dose
Radiation dose
Measured: at discharge up to 15 days after the procedure
Dose of contrast agent
Dose of contrast agent
Measured: at discharge up to 15 days after the procedure
Procedure cost
Costs: Expenses related to the consumption of medical resources, such as costs of medical equipment and personnel; costs for hospitalization of research participants
Measured: at discharge up to 15 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start26 Apr 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Jul 2028 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaopeng Hu, China National Center for Cardiovascular Diseases
- Investigators
- Xiaopeng Hu, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital, BeijingXiangbin Pan, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317804
- Sponsor's protocol ID
- 2025-2761
- Acronym
- ECHO-TAVR
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07317804
- Acronym / sponsor ID
- ECHO-TAVR / 2025-2761
- Keywords
- Ultrasound-guided, Percutaneous Intervention, TAVI(Transcatheter Aortic Valve Implantation), TAVI, Aortic Stenosis, PAN Procedure, non fluoroscopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 26 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 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.
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise.
Transcatheter aortic valve replacement (TAVR/TAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy.
Conventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff.
Echocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary.
To address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echocardiography-guided group | Experimental | Device: Echocardiographic guidancePatients randomized to the echocardiography-guided group will undergo a TAVI procedure under solely echo guidance. |
| Fluoroscopy-guided intervention | Active comparator | Device: Fluoroscopic guidancePatients randomized to the fluoroscopy-guided group will undergo a TAVI procedure under the guidance of X-ray |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 1. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area < 1.0 cm² or peak velocity ≥ 4.0 m/s or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area < 1.0 cm², mean transvalvular pressure difference < 40 mmHg, left ventricular ejection fraction < 50%, stroke volume index < 35 ml/m², and diagnosed as true severe aortic valve stenosis by dobutamine stress test);
- 2. Patients aged 65 years ≤ age < 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery;
- 3. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound;
- 4. The patient has signed the informed consent form and is willing to participate in this study.
Key exclusion criteria (17 listed)
- 1. Imaging (ultrasound and/or CT and/or MRI) confirmed a lesion, thrombus or calculus in the left ventricle;
- 2. Severe obstruction of the left ventricular outflow tract;
- 3. Severe right ventricular dysfunction;
- 4. Acute myocardial infarction within 30 days before the procedure;
- 5. Active endocarditis history within 180 days before the procedure;
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 |
|---|---|---|
| Echocardiographic guidanceAfter detailed evaluation, patients randomized in this group will undergo TAVI procedure under guidance of fully echocardiography but any fluoroscopy in the entire process. | Device | Echocardiography-guided group |
| Fluoroscopic guidanceAfter detailed evaluation, patients randomized in this group will undergo TAVI procedure under combined guidance of echocardiography and fluoroscopy in the entire process. | Device | Fluoroscopy-guided intervention |
Primary outcome
Device success
Time frame: at the time of the participants' discharge up to 15 days after the procedure
Device success (at discharge，from the VARC-3 (Valve Academic Research Consortium - 3)) required the fulfillment of all of the following conditions: 1. Technical success; 2. No death; 3. No additional surgery or intervention was required due to device-related, important vascular/pathway-related complications or cardiac structural complications related to the device (excluding permanent pacemakers); 4. The valve achieved the expected performance (average transvalvular pressure difference < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and no more than moderate-grade valve intra-aneurysmal reflux or paravalvular leakage).
20 secondary outcomes
Technique success
Time frame: evaluated at the time of leaving the operating room
Device success
Time frame: at 30 days after the procedure
The all-cause mortality rate
Time frame: at 30 days, 1 year after the procedure
Cardiovascular mortality
Time frame: at 30 days, 1 year after the procedure
stroke
Time frame: at 30 days, 1 year after the procedure
vascular complications
Time frame: at 30 days, 1 year after the procedure
bleeding (including VARC-3 grade severe bleeding, life-threatening bleeding, and fatal bleeding)
Time frame: at 30 days, 1 year after the procedure
acute kidney injury
Time frame: at 30 days, 1 year after the procedure
The permanent pacemaker implantation(due to new conduction abnormalities or the aggravation of existing conduction abnormalities)
Time frame: at 30 days, 1 year after the procedure
coronary artery blockages that require intervention
Time frame: at 30 days, 1 year after the procedure
valve stenosis or regurgitation (perivalvular and central)
Time frame: at 30 days, 1 year after the procedure
The rehospitalization due to aortic valve stenosis or surgical complications
Time frame: at 30 days, 1 year after the procedure
new-onset atrial fibrillation
Time frame: at 30 days, 1 year after the procedure
structural valve regurgitation of the bioprosthetic aortic valve (as defined by VARC-3)
Time frame: at 30 days, 1 year after the procedure
Length of procedure
Time frame: at discharge up to 15 days after the procedure
Length of hospital stay
Time frame: at discharge up to 15 days after the procedure
fluoroscopy time
Time frame: at discharge up to 15 days after the procedure
Radiation dose
Time frame: at discharge up to 15 days after the procedure
Dose of contrast agent
Time frame: at discharge up to 15 days after the procedure
Procedure cost
Time frame: at discharge up to 15 days after the procedure
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 21 Apr 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.
Xiaopeng Hu, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Xiangbin Pan principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echocardiographic guidance and Fluoroscopic guidance in people with Aortic Stenosis and TAVI, run by China National Center for Cardiovascular Diseases 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 17 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 21 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaopeng Hu, MD,PhD (+86-13621188439, 13621188439@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: at the time of the participants' discharge up to 15 days after the 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 21 Apr 2026.