Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

NCT06924151 | Recruiting DMC

• 1 other identifier: AMETHYST-001
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)

  at 1 year post procedure

Secondary Outcomes (14)

• the rate of all-cause mortality or disabling stroke

  at one year

• the rate of all-cause mortality

  at one year

• the rate of all stroke

  at one year

• the rate of disabling stroke

  at one year

• the rate of rehospitalization (valve-related or procedure-related and including heart failure)

  at one year

Other Outcomes (21)

• All cause mortality

  at 30 days

• The rate of all stroke (disabling and nondisabling)

  at 30 days

• The rate of Rehospitalization (valve-related or procedure-related and including heart failure)

  at 30 days

Study Arms (2)

Surgical aortic valve replacement

EXPERIMENTAL

Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference

Procedure: surgical aortic valve replacement

Transcatheter aortic valve replacement

ACTIVE COMPARATOR

Transcatheter aortic valve replacement (TAVR) using the device available in Japan in facilities approved to perform TAVR.

Procedure: Transcatheter aortic valve replacement

Interventions

surgical aortic valve replacement PROCEDURE

SAVR

Surgical aortic valve replacement

Transcatheter aortic valve replacement PROCEDURE

TAVR

Transcatheter aortic valve replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• History of cardiovascular surgery or thoracotomy
• Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.
• Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.
• Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.
• Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization
• Aortic valve is unicuspid
• Severe aortic regurgitation (\>3+)
• Severe mitral regurgitation (\>3+) or ≥ moderate stenosis
• Severe tricuspid regurgitation (\>3+) or ≥ moderate stenosis
• Pre-existing mechanical or bioprosthetic valve in any position.
• Complex coronary artery disease:
• Heart Team assessment that CABG is recommended at the time of SAVR
• Heart Team assessment that optimal revascularization cannot be performed
• Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization

Sponsors & Collaborators

• Osaka University: lead

Study Sites (37)

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, Aichi-ken, 4538511, Japan

NOT YET RECRUITING

New Tokyo Hospital

Matsudo, Chiba, 2402232, Japan

RECRUITING

Chibanishi General Hospital

Matsudo, Chiba, 2702251, Japan

RECRUITING

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, 2790001, Japan

RECRUITING

Fukui Cardiovascular center

Fukui-shi, Fukui, 910-0833, Japan

NOT YET RECRUITING

Kyushu Univerisity

Fukuoka, Fukuoka, 8128582, Japan

RECRUITING

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

RECRUITING

Kurume University

Kurume, Fukuoka, 8300011, Japan

RECRUITING

Hyogo Medical University

Nishinomiya, Hyōgo, 6638501, Japan

RECRUITING

Kagoshima Medical Center

Kagoshima, Kagoshima-ken, 8920853, Japan

NOT YET RECRUITING

Tokai University

Isehara, Kanagawa, 2591193, Japan

RECRUITING

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 2478533, Japan

RECRUITING

Kawasakisaiwai Hospital

Kawasaki, Kanagawa, 2120014, Japan

RECRUITING

St.Marianna University School of Medicine

Kawasaki, Kanagawa, 2168511, Japan

RECRUITING

Chikamori Hospital

Kochi, Kochi, 7808522, Japan

RECRUITING

Kumamoto University

Kumamoto, Kumamoto, 8608556, Japan

RECRUITING

Shinshu University

Matsumoto, Nagano, 3908621, Japan

RECRUITING

Nagasaki University

Nagasaki, Nagasaki, 8528501, Japan

RECRUITING

Niigata University Medical and Dental Hospital

Niigata, Niigata, 951-8520, Japan

RECRUITING

The Sakakibara Heart Institute of Okayama

Okayama, Okayama-ken, 7000804, Japan

RECRUITING

Yuuai Medical Center

Tomigusuku, Okinawa, 9010224, Japan

RECRUITING

Kishiwada Tokusyukai Hospital

Kishiwada, Osaka, 5960042, Japan

RECRUITING

Osaka International Medical and Science Center

Osaka, Osaka, 5438922, Japan

RECRUITING

Osaka General Medical Center

Osaka, Osaka, 558-8558, Japan

RECRUITING

Osaka Rosai Hospital

Sakai, Osaka, 591-8025, Japan

RECRUITING

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, 3501298, Japan

RECRUITING

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 4308558, Japan

RECRUITING

Hamamatsu University Shool of Medicine

Hamamatsu, Shizuoka, 4313192, Japan

RECRUITING

Shizuoka General Hospital

Shizuoka, Shizuoka, 4208527, Japan

RECRUITING

Dokkyo Medical University

Shimotsuga, Tochigi, 3210293, Japan

RECRUITING

Tokushima University

Tokushima, Tokushima, 7708503, Japan

RECRUITING

Sakakibara Heart Institute

Fuchū, Tokyo, 1830003, Japan

RECRUITING

Tokyo Women's Medical University

Shinjuku, Tokyo, 1628666, Japan

RECRUITING

Tottori University

Yonago, Tottori, 6838504, Japan

RECRUITING

Wakayama Medical University

Wakayama, Wakayama, 6418509, Japan

RECRUITING

Oita University

Ōita, Yufu, 879-5593, Japan

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Koichi Maeda, M.D.

CONTACT

+81 -6-6879-3154; k-maeda@surg1.med.osaka-u.ac.jp

Shigeru Miyagawa, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: April 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2037
• Last Updated: August 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (37)