RecruitingNCT07030062
Echocardiography Guided TAVR (Echo TAVR)
Transcatheter Aortic Valve Replacement With Echocardiography Guidance
Sponsor
Pan Xiangbin
Enrollment
20 participants
Start Date
Feb 18, 2025
Study Type
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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);
- a history of malignancy or a high familial risk of cancer, with refusal to undergo contrast- or radiation-guided procedures;
- chronic kidney disease and refuse to receive contrast agents or radiation exposure.
Exclusion Criteria1
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07030062
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