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Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500964
Recruitment Status : Completed
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Luca Testa, IRCCS Policlinico S. Donato

Brief Summary:

Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).

The purpouse of this study is to evaluate the indication to a second TAVR, the selection criteria of the second transcatheter aortic valve, procedural and clinical outcomes.

The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year


Condition or disease Intervention/treatment
Failed Transcather Aortic Valve Device: TAVR

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Study Type : Observational [Patient Registry]
Actual Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : July 1, 2020

Group/Cohort Intervention/treatment
failed transcather aortic valve (Stenotic) Device: TAVR
Trancatheter aortic valve replacement

failed transcather aortic valve (Regurgitation) Device: TAVR
Trancatheter aortic valve replacement

failed transcather aortic valve (Regurgitation and stenotic)) Device: TAVR
Trancatheter aortic valve replacement




Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 1 year ]
    Overall mortality and Cardiovascular mortality at 1 year


Secondary Outcome Measures :
  1. VARC-3 Events [ Time Frame: 1 year ]
    Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with failed transcather aortic valve
Criteria

Inclusion Criteria:

  • Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).

Exclusion Criteria:

-


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): NCT04500964


Locations
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Italy
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
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Responsible Party: Luca Testa, Interventional Cardiology, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT04500964    
Other Study ID Numbers: TRANSIT
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No