The CONFIDENCE Registry

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1000
  • sponsor
    Abbott Medical Devices
Updated on 12 July 2020
Investigator
Mira Tissari
Primary Contact
Kliniken der Friedrich-Alexander-Universitat (8.7 mi away) Contact
+31 other location

Summary

The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.

Description

The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.

Approximately 1000 subjects with severe symptomatic (NYHA class II) aortic stenosis (AS), will undergo Portico Transcatheter Aortic Heart Valve implantation.

The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.

Details
Treatment Portico™ Valve, Delivery System(s) and Loading Systems(s)
Clinical Study IdentifierNCT03752866
SponsorAbbott Medical Devices
Last Modified on12 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Symptomatic Degenerative Aortic Stenosis or Severe Aortic Stenosis?
Subjects who are >18 years of age or legal age in host country and have been identified as a candidate for a Portico valve implant
Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center

Exclusion Criteria

Candidates will be excluded if any of the following conditions are present
Have sepsis, including active endocarditis
Have any evidence of left ventricular or atrial thrombus
Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
Have a non-calcified aortic annulus
Have congenital bicuspid or unicuspid leaflet configuration
Are unable to tolerate antiplatelet/anticoagulant therapy
Are pregnant at the time of signing informed consent
Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
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