NCT02838199

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
55mo left

Started Dec 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Dec 2016Dec 2030

First Submitted

Initial submission to the registry

July 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
10.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

3.5 years

First QC Date

July 6, 2016

Last Update Submit

November 22, 2016

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacementTAVRTAVISAVR

Outcome Measures

Primary Outcomes (1)

  • event rate of all-cause mortality

    1 year

Secondary Outcomes (25)

  • event rate of cardiovascular mortality

    30 days or hospital discharge, whichever is longer

  • event rate of cardiovascular mortality

    31 days to the 1 year

  • event rate of myocardial Infarction

    30 days or hospital discharge, whichever is longer

  • event rate of myocardial Infarction

    31 days to the 1 year

  • event rate of all Stroke and transient ischemic attack

    30 days or hospital discharge, whichever is longer

  • +20 more secondary outcomes

Study Arms (2)

TAVR

EXPERIMENTAL

Transcatheter aortic valve replacement with SAPIEN 3

Device: SAPIEN 3

SAVR

ACTIVE COMPARATOR

Surgical aortic valve replacement

Procedure: SAVR

Interventions

SAPIEN 3DEVICE
TAVR
SAVRPROCEDURE
SAVR

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 cm2. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Suck-jung Choo, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 20, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2020

Study Completion (Estimated)

December 1, 2030

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

KR(1)