Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT07317804
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100037, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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:
Time frame: evaluated at the time of leaving the operating room
technique success, according to the definition of technical success in the VARC-3, must meet all of the following conditions:
Time frame: at 30 days after the procedure
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:
Time frame: at 30 days, 1 year after the procedure
The all-cause mortality rate
Time frame: at 30 days, 1 year after the procedure
Cardiovascular mortality rate
Time frame: at 30 days, 1 year after the procedure
The incidence of stroke
Time frame: at 30 days, 1 year after the procedure
The incidence of vascular complications
Time frame: at 30 days, 1 year after the procedure
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
The incidence of acute kidney injury
Time frame: at 30 days, 1 year after the procedure
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
The incidence of coronary artery blockages that require intervention
Time frame: at 30 days, 1 year after the procedure
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 re-hospitalization rate due to aortic valve stenosis or surgical complications
Time frame: at 30 days, 1 year after the procedure
The incidence of new-onset atrial fibrillation
Time frame: at 30 days, 1 year after the procedure
The incidence of structural valve regurgitation of the bioprosthetic aortic valve (as defined by VARC-3)
Time frame: at discharge up to 15 days 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
Costs: Expenses related to the consumption of medical resources, such as costs of medical equipment and personnel; costs for hospitalization of research participants
Contact information is provided by the study sponsor or research team.
Ning Zhou
CONTACT
Xiaopeng Hu, MD,PhD
CONTACT
China National Center for Cardiovascular Diseases
Other Gov
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis
Acronym: ECHO-TAVR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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