Clinical trial Recruiting at 1 site Observational

Echocardiography-guided transcatheter aortic valve replacement (Echo TAVR)

Official title: Transcatheter Aortic Valve Replacement With Echocardiography Guidance

Run by Chinese Academy of Medical Sciences, Fuwai Hospital · NCT07030062 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment20 (estimated)
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Beijing)
StatusRecruiting
StartedFebruary 18, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedJune 19, 2025
Trial IDNCT07030062 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Fuwai Hospital
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.