Status:
COMPLETED
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Lead Sponsor:
Abbott Medical Devices
Conditions:
Symptomatic Degenerative Aortic Stenosis
Severe Aortic Stenosis
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 wit...
Detailed 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)...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT03752866
Start Date
October 25 2018
End Date
July 28 2022
Last Update
October 21 2024
Active Locations (28)
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1
Heart Care Partners- Wesley Hospital
Woolloongabba, Queensland, Australia, 4102
2
AZ Middelheim
Antwerp, Belgium, 2020
3
University Hospital Olomouc
Olomouc, Czechia, 77900
4
Kliniken der Friedrich-Alexander-Universitat
Erlangen, Bavaria, Germany, 91054