Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.

Aortic Valve Stenosis Clinical Trial

— CENTER  

Official title:

Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588247
• Other study ID #: CENTER-study
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. In the absence of large randomized controlled trials, we will conduct a large collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients undergoing primary transfemoral TAVI with either MCV or ES valve.

Description:

The main aim of this patient-pooled analyses is to compare stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. However, this collaboration may also be used to compare various outcomes.

Studies were included if they complied with the following requirements: original prospective studies, including patients with aortic valve stenosis treated with transfemoral TAVI of native valves and reporting of 30 day stroke outcomes according to VARC criteria or other specified corresponding criteria . Moreover, to be included studies had to report both the use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50 patients in each arm to ensure experience in use of the valves. Studies were excluded if they only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or included the same study population. Principal Investigators of these studies were approached for collaboration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: January 1, 2023
• Est. primary completion date: June 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion Criteria:

• valve-in-valve procedures, other acces routes than transfemoral

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• transcatheter aortic valve implantation
Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death during the first month after TAVI	30 days
Primary	Stroke	Stroke during the first month after TAVI	30 days
Secondary	Pacemaker implantation	Pacemaker during the first month after TAVI	30 days
Secondary	Bleeding	Major or life-threatening bleeding during the first month after TAVI	30 days
Secondary	New onset atrial fibrillation	New onset atrial fibrillation during the first month after TAVI	30 days
Secondary	Myocardial infarction	Myocardial infarction during the first month after TAVI	30 days