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

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• All study participants must meet the following inclusion criteria 1. Severe, calcific aortic stenosis with the following criteria:

‣ Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR

⁃ AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90 days prior to randomization

• AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercise capacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patients with LVEF \<50%

• The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately captured by risk calculators such as STS-PROM, in addition to the risk score itself.

• The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.

Locations
Other Locations
Japan
Sakakibara Heart Institute
RECRUITING
Fuchū
Fukui Cardiovascular center
NOT_YET_RECRUITING
Fukui-shi
Kyushu Univerisity
RECRUITING
Fukuoka
Hamamatsu University Shool of Medicine
RECRUITING
Hamamatsu
Seirei Hamamatsu General Hospital
RECRUITING
Hamamatsu
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Tokai University
RECRUITING
Isehara
Kagoshima Medical Center
NOT_YET_RECRUITING
Kagoshima
Shonan Kamakura General Hospital
RECRUITING
Kamakura
Kawasakisaiwai Hospital
RECRUITING
Kawasaki
St.Marianna University School of Medicine
RECRUITING
Kawasaki
Kishiwada Tokusyukai Hospital
RECRUITING
Kishiwada
Kokura Memorial Hospital
RECRUITING
Kitakyushu
Chikamori Hospital
RECRUITING
Kochi
Kumamoto University
RECRUITING
Kumamoto
Kurume University
RECRUITING
Kurume
Chibanishi General Hospital
RECRUITING
Matsudo
New Tokyo Hospital
RECRUITING
Matsudo
Shinshu University
RECRUITING
Matsumoto
Nagasaki University
RECRUITING
Nagasaki
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
NOT_YET_RECRUITING
Nagoya
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
Hyogo Medical University
RECRUITING
Nishinomiya
Oita University
RECRUITING
Ōita
The Sakakibara Heart Institute of Okayama
RECRUITING
Okayama
Osaka General Medical Center
RECRUITING
Osaka
Osaka International Medical and Science Center
RECRUITING
Osaka
Osaka Rosai Hospital
RECRUITING
Sakai
Kinki University Hospital
RECRUITING
Sayama
Dokkyo Medical University
RECRUITING
Shimotsuga
Tokyo Women's Medical University
RECRUITING
Shinjuku
Shizuoka General Hospital
RECRUITING
Shizuoka
Tokushima University
RECRUITING
Tokushima
Yuuai Medical Center
RECRUITING
Tomigusuku
Tokyo Bay Urayasu Ichikawa Medical Center
RECRUITING
Urayasu
Wakayama Medical University
RECRUITING
Wakayama
Tottori University
RECRUITING
Yonago
Contact Information
Primary
Koichi Maeda, M.D.
k-maeda@surg1.med.osaka-u.ac.jp
+81 -6-6879-3154
Backup
Shigeru Miyagawa, M.D.
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2037-05-31
Participants
Target number of participants: 800
Treatments
Experimental: Surgical aortic valve replacement
Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference
Active_comparator: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement (TAVR) using the device available in Japan in facilities approved to perform TAVR.
Sponsors
Leads: Osaka University

This content was sourced from clinicaltrials.gov