Echocardiography Guided TAVR (Echo TAVR)
Launched by PAN XIANGBIN · Jun 12, 2025
Trial Information
Current as of July 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to perform a procedure called transcatheter aortic valve replacement (TAVR), which is used to treat severe narrowing of the aortic valve in the heart. Normally, TAVR uses X-rays and special dye (contrast agents) to guide the procedure, but these can be risky for some patients, especially those with kidney problems or a history of cancer. This study is testing whether using ultrasound imaging (echocardiography) instead can be a safer and effective alternative to guide the valve replacement without the need for radiation or dye.
People who might be eligible for this trial include adults with severe symptoms caused by a narrowed aortic valve, confirmed by ultrasound tests, and who either have a history of cancer, a high risk of cancer, or kidney disease that makes them want to avoid X-rays and contrast dye. Participants will undergo the valve replacement using ultrasound guidance, which could reduce their exposure to radiation and harmful dyes. It’s important that they do not have other major heart conditions needing treatment at the same time or have already had valve replacement surgery. This study is currently recruiting patients who fit these criteria and are interested in a potentially safer option for their valve procedure.
Gender
ALL
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.
About Pan Xiangbin
Pan Xiangbin is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing novel therapeutics and enhancing patient outcomes, the organization leverages cutting-edge methodologies and a robust network of clinical sites. Pan Xiangbin emphasizes rigorous compliance with regulatory standards and ethical considerations, ensuring the integrity and reliability of its research. Through collaborative partnerships and a patient-centric approach, the sponsor aims to contribute significantly to the fields of pharmaceuticals and biotechnology, ultimately improving healthcare solutions for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported