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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

Tracking Information
First Submitted Date August 3, 2020
First Posted Date August 6, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date January 1, 2019
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2020)
Overall mortality [ Time Frame: 1 year ]
Overall mortality and Cardiovascular mortality at 1 year
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 3, 2020)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve
Official Title Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry
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

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with failed transcather aortic valve
Condition Failed Transcather Aortic Valve
Intervention Device: TAVR
Trancatheter aortic valve replacement
Study Groups/Cohorts
  • failed transcather aortic valve (Stenotic)
    Intervention: Device: TAVR
  • failed transcather aortic valve (Regurgitation)
    Intervention: Device: TAVR
  • failed transcather aortic valve (Regurgitation and stenotic))
    Intervention: Device: TAVR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2020)
173
Original Actual Enrollment Same as current
Actual Study Completion Date July 1, 2020
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04500964
Other Study ID Numbers TRANSIT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Luca Testa, IRCCS Policlinico S. Donato
Study Sponsor IRCCS Policlinico S. Donato
Collaborators Not Provided
Investigators Not Provided
PRS Account IRCCS Policlinico S. Donato
Verification Date August 2020