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

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ClinicalTrials.gov Identifier: NCT03588247
Recruitment Status : Unknown
Verified July 2018 by Jan Piek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jan Piek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: transcatheter aortic valve implantation

Detailed 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: transcatheter aortic valve implantation
    Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Death during the first month after TAVI

  2. Stroke [ Time Frame: 30 days ]
    Stroke during the first month after TAVI


Secondary Outcome Measures :
  1. Pacemaker implantation [ Time Frame: 30 days ]
    Pacemaker during the first month after TAVI

  2. Bleeding [ Time Frame: 30 days ]
    Major or life-threatening bleeding during the first month after TAVI

  3. New onset atrial fibrillation [ Time Frame: 30 days ]
    New onset atrial fibrillation during the first month after TAVI

  4. Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction during the first month after TAVI


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients undergoing transfemoral transcatheter aortic valve procedures
Criteria

Inclusion Criteria:

  • patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion Criteria:

  • valve-in-valve procedures, other acces routes than transfemoral
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588247


Contacts
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Contact: Wieneke Vlastra, MD +31205667883 w.vlastra@amc.uva.nl
Contact: Ronak Delewi, MD, PhD +31205667883 r.delewi@amc.uva.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Jan Piek, Prof.       j.j.piek@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jan Piek, Prof. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jan Piek, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03588247    
Other Study ID Numbers: CENTER-study
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Collaborators are invited to participate in analyses

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction