A Phase 4 interventional study of Echocardiographic guidance and Fluoroscopic guidance in Aortic Stenosis, TAVI and TAVI(Transcatheter Aortic Valve Implantation), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 212 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to the echocardiography-guided group will undergo a TAVI procedure under solely echo guidance.
Device: Echocardiographic guidance
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 guidance of fully echocardiography but any fluoroscopy in the entire process.
After detailed evaluation, patients randomized in this group will undergo TAVI procedure under combined guidance of echocardiography and fluoroscopy in the entire process.
Device success
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).
Time frame: at the time of the participants' discharge up to 15 days after the procedure
Technique success
technique success, according to the definition of technical success in the VARC-3, must meet all of the following conditions: 1. No death; 2. Successful establishment of vascular access, implantation of the valve, and withdrawal from the delivery system; 3. Correct placement of a single artificial heart valve in the appropriate anatomical position; 4. No surgical or interventional procedures due to complications from instruments, major blood vessels or access routes, or cardiac structures.
Time frame: 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: 1. Technical success; 2. No death; 3. No surgical or interventional procedures due to complications from the device, main blood vessels or access, or cardiac structures; 4. 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).
Time frame: at 30 days after the procedure
The all-cause mortality rate
The all-cause mortality rate
Time frame: at 30 days, 1 year after the procedure
Cardiovascular mortality
Cardiovascular mortality rate
Time frame: at 30 days, 1 year after the procedure
stroke
The incidence of stroke
Time frame: at 30 days, 1 year after the procedure
vascular complications
The incidence of 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)
The incidence of postoperative 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
The incidence of 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)
The permanent pacemaker implantation rate (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
The incidence of coronary artery blockages that require intervention
Time frame: 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)
Time frame: 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
Time frame: at 30 days, 1 year after the procedure
new-onset atrial fibrillation
The incidence of 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)
The incidence of 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
Length of procedure
Time frame: at discharge up to 15 days after the procedure
Length of hospital stay
Length of hospital stay
Time frame: at discharge up to 15 days after the procedure
fluoroscopy time
fluoroscopy time
Time frame: at discharge up to 15 days after the procedure
Radiation dose
Radiation dose
Time frame: at discharge up to 15 days after the procedure
Dose of contrast agent
Dose of contrast agent
Time frame: 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
Time frame: at discharge up to 15 days after the procedure
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases