Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR） (ECHO-TAVR)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis; TAVI; TAVI(Transcatheter Aortic Valve Implantation)
• Intervention / Treatment: Device: Echocardiographic guidance; Device: Fluoroscopic guidance

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaopeng Hu, MD,PhD; Phone Number: +86-13621188439; Email: 13621188439@139.com
• Study Contact Backup: Name: Ning Zhou; Phone Number: +86-19220152862; Email: fwzhouning@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
      • Contact: Xiaopeng Hu, MD.PhD; Phone Number: +86-13621188439; Email: 13621188439@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echocardiography-guided group; Patients randomized to the echocardiography-guided group will undergo a TAVI procedure under solely echo guidance.	Device: Echocardiographic guidance; After detailed evaluation, patients randomized in this group will undergo TAVI procedure under guidance of fully echocardiography but any fluoroscopy in the entire process.
Active Comparator: Fluoroscopy-guided intervention; Patients randomized to the fluoroscopy-guided group will undergo a TAVI procedure under the guidance of X-ray	Device: Fluoroscopic guidance; After detailed evaluation, patients randomized in this group will undergo TAVI procedure under combined guidance of echocardiography and fluoroscopy in the entire process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at the time of the participants' discharge up to 15 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	at 30 days after the procedure
The all-cause mortality rate	The all-cause mortality rate	at 30 days, 1 year after the procedure
Cardiovascular mortality	Cardiovascular mortality rate	at 30 days, 1 year after the procedure
stroke	The incidence of stroke	at 30 days, 1 year after the procedure
vascular complications	The incidence of vascular complications	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)	at 30 days, 1 year after the procedure
acute kidney injury	The incidence of acute kidney injury	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)	at 30 days, 1 year after the procedure
coronary artery blockages that require intervention	The incidence of coronary artery blockages that require intervention	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)	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	at 30 days, 1 year after the procedure
new-onset atrial fibrillation	The incidence of new-onset atrial fibrillation	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)	at 30 days, 1 year after the procedure
Length of procedure	Length of procedure	at discharge up to 15 days after the procedure
Length of hospital stay	Length of hospital stay	at discharge up to 15 days after the procedure
fluoroscopy time	fluoroscopy time	at discharge up to 15 days after the procedure
Radiation dose	Radiation dose	at discharge up to 15 days after the procedure
Dose of contrast agent	Dose of contrast agent	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	at discharge up to 15 days after the procedure

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xiaopeng Hu, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing; Principal Investigator: Xiangbin Pan, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): April 26, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound-guided; Aortic Stenosis; TAVI; Percutaneous Intervention; PAN Procedure; non fluoroscopic; TAVI(Transcatheter Aortic Valve Implantation)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2025-2761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No