NCT03163329

Brief Summary

Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_2

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

May 20, 2017

Last Update Submit

January 10, 2018

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality, all stroke, and re-hospitalization

    This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%

    1 year post procedure

Study Arms (2)

TAVR group

EXPERIMENTAL
Procedure: TAVR

SAVR group

ACTIVE COMPARATOR
Procedure: SAVR

Interventions

TAVRPROCEDURE

Transcatheter Aortic Valve Replacement

TAVR group
SAVRPROCEDURE

Surgical Aortic Valve Replacement

SAVR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe, calcific bicuspid aortic stenosis.
  • Heart team agrees the patient has a risk of operative mortality and has an STS \<8 and \>3.
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

You may not qualify if:

  • Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  • Severe aortic regurgitation (\>3+).
  • Severe mitral regurgitation (\>3+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Yong-jian Wu, M.D, Ph.D

CONTACT

0086-10-88396780fuwaihospital@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 23, 2017

Study Start

February 1, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2024

Last Updated

January 11, 2018

Record last verified: 2018-01