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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | February 18, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT07030062 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
- Study coordinator: Xiangbin Pan, MD
- Email: panxiangbin@fuwaihospital.org
- Phone: 88396655
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single-beat TE-e' for estimating left atrial pressure in critically ill patients
A noninvasive test using a single-beat TE-e' echocardiography measurement is being tried to see if it can reliably indicate elevated left atrial pressure in critically ill adults.
-
Automated Echocardiography Measurements Using Deep-Learning Software
This study tests whether US2.AI can automatically measure heart structure and function from standard echocardiograms as accurately as expert clinicians in adults.
-
Cardiac and carotid ultrasound reference values in healthy children in Italy
This study tests heart and artery measurements to establish normal reference values for healthy kids in Italy.
-
DigitHeart Echo: predicting heart ultrasound findings from a smartphone photo of your ECG
This test checks whether a smartphone app can predict echocardiogram findings from a photo of a 12‑lead ECG in adults scheduled for echocardiography.
-
COMA.NET: Targeted treatment for coronary microcirculation problems
This trial will test whether tailoring medicines based on intracoronary microvascular testing improves quality of life for people with ischemia but no large artery blockages.
-
Global longitudinal strain to predict difficult separation from cardiopulmonary bypass
This will test whether a heart ultrasound measure called global longitudinal strain (GLS) can predict which adults having elective cardiac surgery will have trouble coming off cardiopulmonary bypass.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.