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Recruiting Observational

Echocardiography Guided TAVR (Echo TAVR)

NCT07030062 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-02-18
Last updated
2025-06-19

Condition(s) studied

Transcatheter Aortic Valve ReplacemenEchocardiography

Study summary

Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable. Echocardiography guidance TAVR can offer a feasible and safer strategy for TAVR.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Valve Academic Research Consortium-3 (VARC-3) — 30-day after surgery
    VARC3 include but not limited to Mortality (all-cause and cardiovascular) Stroke and transient ischemic attack (TIA) Acute kidney injury Conduction disturbances and permanent pacemaker implantation Bleeding (updated using BARC criteria) Myocardial infarction Vascular access complications Endocarditis

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07030062 on ClinicalTrials.gov ↗ ← All trials in China