RecruitingNot ApplicableNCT06924151

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

the Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of Isolated Surgical Aortic Valve Replacement in Low Risk Patients Who Have Symptomatic Severe Aortic Stenosis

Sponsor

Osaka University

Enrollment

450 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Stenosis

Summary

To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Transcatheter aortic valve replacement and a procedure called surgical aortic valve replacement for people with aortic stenosis. The study is currently recruiting participants at 37 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsurgical aortic valve replacement

SAVR

PROCEDURETranscatheter aortic valve replacement

TAVR

Locations(37)

New Tokyo Hospital

Matsudo, Chiba, Japan

Chibanishi General Hospital

Matsudo, Chiba, Japan

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Kurume University

Kurume, Fukuoka, Japan

Hyogo Medical University

Nishinomiya, Hyōgo, Japan

Tokai University

Isehara, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Kawasakisaiwai Hospital

Kawasaki, Kanagawa, Japan

St.Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Shinshu University

Matsumoto, Nagano, Japan

Yuuai Medical Center

Tomigusuku, Okinawa, Japan

Kishiwada Tokusyukai Hospital

Kishiwada, Osaka, Japan

Osaka Rosai Hospital

Sakai, Osaka, Japan

Kinki University Hospital

Sayama, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Hamamatsu University Shool of Medicine

Hamamatsu, Shizuoka, Japan

Dokkyo Medical University

Shimotsuga, Tochigi, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Tokyo Women's Medical University

Shinjuku, Tokyo, Japan

Tottori University

Yonago, Tottori, Japan

Oita University

Ōita, Yufu, Japan

Kansai Rosai Hospital

Amagasaki, Japan

Kyushu Univerisity

Fukuoka, Japan

Chikamori Hospital

Kochi, Japan

Kumamoto University

Kumamoto, Japan

Nagasaki University

Nagasaki, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

The Sakakibara Heart Institute of Okayama

Okayama, Japan

Osaka International Medical and Science Center

Osaka, Japan

Osaka General Medical Center

Osaka, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Shizuoka General Hospital

Shizuoka, Japan

National cerebral and cardiovascular center

Suita, Japan

Tokushima University

Tokushima, Japan

Wakayama Medical University

Wakayama, Japan

View Full Details on ClinicalTrials.gov

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NCT06924151

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