The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis

Aortic Valve Disease Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03163329
• Other study ID #: AS-20170520
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 20, 2017
• Last updated: January 10, 2018
• Start date: February 1, 2018
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2018
• Source: China National Center for Cardiovascular Diseases
• Contact: Yong-jian Wu, M.D, Ph.D
• Phone: 0086-10-88396780
• Email: fuwaihospital[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Severe, calcific bicuspid aortic stenosis.

2. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >3.

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.

Exclusion Criteria:

1. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.

2. Evidence of an acute myocardial infarction = 1 month (30 days) before randomization.

3. Severe aortic regurgitation (>3+).

4. Severe mitral regurgitation (>3+).

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

Procedure:
• TAVR
Transcatheter Aortic Valve Replacement
• SAVR
Surgical Aortic Valve Replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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