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Clinical Trials/NCT02838199
NCT02838199WithdrawnPhase 4

Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

Seung-Jung Park2 sites in 1 countryStarted: December 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
event rate of all-cause mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age must be at least 19 and less than 75 years old
  • •Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm
  • •Echocardiogram must be within 3 months of the date of the procedure
  • •Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
  • •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

  • •Life expectancy <1 year due to medical illness
  • •Suspected Malignancy
  • •Inoperability evaluated by surgeon
  • •Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
  • •Concomitant severe mitral valve or significant aorta disease requiring surgery
  • •Active bacterial endocarditis within 6 months of procedure
  • •Leukopenia (WBC<3000 cell/mL), acute anemia (Hgb<8g/dL), thrombocytopenia (platelet < 50000 cell/mL)
  • •Intracardiac thrombus
  • •A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  • •Native aortic annulus size < 18 mm or > 25 mm as measured by echocardiogram.
  • •Expectation that patient will not improve despite treatment of aortic stenosis
  • •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Outcomes

Primary Outcomes

event rate of all-cause mortality

Time Frame: 1 year

Secondary Outcomes

  • event rate of myocardial Infarction(31 days to the 1 year)
  • event rate of acute kidney injury(31 days to the 1 year)
  • event rate of other TAVR-related complication(31 days to the 1 year)
  • event rate of free from atrial fibrillation(30days and 1 year)
  • event rate of bleeding(31 days to the 1 year)
  • event rate of vascular access site and access-related complication(31 days to the 1 year)
  • event rate of prosthetic valve dysfunction(31 days to the 1 year)
  • event rate of composite event for device success, early safety, clinical efficacy(31 days to the 1 year)
  • event rate of cardiovascular mortality(31 days to the 1 year)
  • event rate of all Stroke and transient ischemic attack(31 days to the 1 year)
  • event rate of structural valve deterioration(31 days to the 1 year)
  • NYHA (New York Heart Association Functional Classification)(30days and 1 year)
  • event rate of permanent pacemaker insertion(31 days to the 1 year)
  • Valve area(30days and 1 year)

Investigators

Sponsor
Seung-Jung Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

professor of medicine

Asan Medical Center

Study Sites (2)

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