Echocardiography-guided transcatheter aortic valve replacement (Echo TAVR)

Transcatheter Aortic Valve Replacement With Echocardiography Guidance

This will test whether performing TAVR guided mainly by echocardiography instead of X‑ray and contrast is feasible and safer for people with severe aortic stenosis who cannot or refuse radiation or contrast exposure.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT07030062 on ClinicalTrials.gov

What this trial studies

This observational study uses echocardiography as the primary imaging guide to perform transcatheter aortic valve replacement, avoiding routine fluoroscopy and iodinated contrast. It enrolls adults with symptomatic severe aortic stenosis who either decline or are advised against contrast or radiation, including those with high cancer risk or chronic kidney disease. Procedures will be done at a single center with collection of procedural details and short-term safety and feasibility outcomes. Key exclusions include need for hybrid/concomitant cardiac interventions, untreated revascularizable coronary disease, prior aortic valve replacement, or prohibitive surgical comorbidity.

Who should consider this trial

Good fit: Ideal candidates are adults with symptomatic severe aortic stenosis who refuse or cannot receive contrast agents or radiation exposure, such as those with high familial cancer risk or chronic kidney disease.

Not a fit: Patients requiring combined cardiac procedures, those with untreated coronary disease amenable to revascularization, those with prior aortic valve replacement, or those deemed inoperable due to extreme comorbidity are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could allow people who cannot receive contrast or radiation to get TAVR with lower risk of kidney injury and radiation exposure.

How similar studies have performed: Limited case series and single-center reports suggest echo-guided or minimal-fluoroscopy TAVR can be feasible, but larger comparative data are still lacking.

Eligibility criteria

Inclusion Criteria:

1. symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, which is defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2);
2. a history of malignancy or a high familial risk of cancer, with refusal to undergo contrast- or radiation-guided procedures;
3. chronic kidney disease and refuse to receive contrast agents or radiation exposure.

Exclusion Criteria:

Required hybrid procedures or concomitant interventions on other cardiac malformations; Deemed inoperable due to extremely high surgical risk or severe comorbidities; Had untreated clinically significant coronary vascular disease amenable to revascularization; Previously undergone aortic valve replacement.

Where this trial is running

Beijing

• Fuwai Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiangbin Pan, MD

Conditions Transcatheter Aortic Valve Replacemen; Echocardiography