Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
NCT06924151 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2025-08-28
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
Interventions
- PROCEDURE
-
surgical aortic valve replacement
SAVR
- PROCEDURE
-
Transcatheter aortic valve replacement
TAVR
Sponsors & Collaborators
-
Osaka University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2028-05-31
- Completion
- 2037-05-31
Countries
- Japan
Study Locations
More Related Trials
-
Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry
NCT05308173 ·Status: COMPLETED
-
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT01531374 ·Status: COMPLETED ·Phase: NA
-
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
NCT05886517 ·Status: RECRUITING ·Phase: NA
-
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
NCT07108478 ·Status: NOT_YET_RECRUITING
-
Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve
NCT04500964 ·Status: COMPLETED
-
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
NCT03025971 ·Status: COMPLETED ·Phase: NA
-
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
NCT02394184 ·Status: COMPLETED
-
Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice
NCT03453567 ·Status: ACTIVE_NOT_RECRUITING
-
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
NCT03836521 ·Status: RECRUITING
-
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
NCT03411304 ·Status: ACTIVE_NOT_RECRUITING
-
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
NCT03112980 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
PrizValve® Transcatheter Aortic Valve Replacement Study
NCT04836897 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
NCT06381271 ·Status: RECRUITING
-
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
NCT02491255 ·Status: COMPLETED ·Phase: NA
-
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
NCT04634240 ·Status: RECRUITING ·Phase: NA
-
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
NCT00986193 ·Status: TERMINATED ·Phase: NA
-
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
NCT03863132 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
NCT02424370 ·Status: COMPLETED
-
Safety and Feasibility of TRISKELE in Severe AS
NCT05391191 ·Status: UNKNOWN ·Phase: NA
-
The TransCatheter Valve and Vessels Trial
NCT03424941 ·Status: COMPLETED ·Phase: NA
-
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
NCT03163329 ·Status: UNKNOWN ·Phase: PHASE2
-
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
NCT06830499 ·Status: RECRUITING
-
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
NCT03094143 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
TAVR for Aortic Valve Disease
NCT05439863 ·Status: RECRUITING
-
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
NCT05310461 ·Status: RECRUITING ·Phase: NA