Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Device success
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Fluoroscopy-guided intervention
Patients randomized to the fluoroscopy-guided group will undergo a TAVI procedure under the guidance of X-ray
Intervention: Fluoroscopic guidance (Device)
Echocardiography-guided group
Patients randomized to the echocardiography-guided group will undergo a TAVI procedure under solely echo guidance.
Intervention: Echocardiographic guidance (Device)
Outcomes
Primary Outcomes
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).
The study adopted the definition of device success from the VARC-3 (Valve Academic Research Consortium - 3) and used the device success rate as the primary outcome measure.
Time Frame: at the time of the participants' discharge up to 15 days after the procedure
Device success (at discharge) 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).
Secondary Outcomes
- Technique success(evaluated at the time of leaving the operating room)
- Device success(at 30 days after the procedure)
- The all-cause mortality rate(at 30 days, 1 year after the procedure)
- Cardiovascular mortality(at 30 days, 1 year after the procedure)
- stroke(at 30 days, 1 year after the procedure)
- vascular complications(at 30 days, 1 year after the procedure)
- bleeding (including VARC-3 grade severe bleeding, life-threatening bleeding, and fatal bleeding)(at 30 days, 1 year after the procedure)
- 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)(at 30 days, 1 year after the procedure)
- coronary artery blockages that require intervention(at 30 days, 1 year after the procedure)
- 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(at 30 days, 1 year after the procedure)
- 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)(at 30 days, 1 year after the procedure)
- Length of procedure(at discharge up to 15 days after the procedure)
- Length of hospital stay(at discharge up to 15 days after the procedure)
- fluoroscopy time(at discharge up to 15 days after the procedure)
- Radiation dose(at discharge up to 15 days after the procedure)
- Dose of contrast agent(at discharge up to 15 days after the procedure)
- Procedure cost(at discharge up to 15 days after the procedure)
- hospital cost(at discharge up to 15 days after procedure)
- technique success(evaluated at the time of leaving the operating room)
- device success(at 30 days after the operation)
- Total hospital stay for TAVR surgery(at discharge up to 15 days after procedure)
- fluoroscopy time(at discharge up to 15 days after procedure)
- Dose of contrast agent(at discharge up to 15 days after procedure)
- Radiation dose(at discharge up to 15 days after procedure)
- time of operation(at discharge up to 15 days after procedure)
- The all-cause mortality rate(at 30 days, 1 year after the operation)
- Cardiovascular mortality(at 30 days, 1 year after the operation)
- stroke(at 30 days, 1 year after the operation)
- vascular complications(at 30 days, 1 year after the operation)
- bleeding (including VARC-3 grade severe bleeding, life-threatening bleeding, and fatal bleeding)(at 30 days, 1 year after the operation)
- acute kidney injury(at 30 days, 1 year after the operation)
- The permanent pacemaker implantation(due to new conduction abnormalities or the aggravation of existing conduction abnormalities)(at 30 days, 1 year after the operation)
- coronary artery blockages that require intervention(at 30 days, 1 year after the operation)
- valve stenosis or regurgitation (perivalvular and central)(at 30 days, 1 year after the operation)
- The re-hospitalization rate due to aortic valve stenosis or surgical complications within(at 30 days, 1 year after the operation)
- new-onset atrial fibrillation(at 30 days, 1 year after the operation)
- structural valve regurgitation of the bioprosthetic aortic valve (as defined by VARC-3)(at 30 days, 1 year after surgery)
Investigators
Xiaopeng Hu
Principal Investigator
China National Center for Cardiovascular Diseases