Brief Title
The CONFIDENCE Registry
Official Title
CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
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 with symptomatic degenerative aortic stenosis.
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) 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.
Study Type
Interventional
Primary Outcome
Cardiovascular Mortality
Condition
Symptomatic Degenerative Aortic Stenosis
Intervention
Portico™ Valve, Delivery System(s) and Loading Systems(s)
Study Arms / Comparison Groups
Portico™ Valve, Delivery System(s) and Loading Systems(s)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1000
Start Date
October 25, 2018
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria: - 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: 1. Have sepsis, including active endocarditis 2. Have any evidence of left ventricular or atrial thrombus 3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 4. Have a non-calcified aortic annulus 5. Have congenital bicuspid or unicuspid leaflet configuration 6. Are unable to tolerate antiplatelet/anticoagulant therapy 7. Are pregnant at the time of signing informed consent 8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Helge Möllmann, +32470470942, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03752866
Organization ID
SJM-CIP-CL1003491
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Helge Möllmann, Principal Investigator, St. Johannes Hospital, Dortmund, Germany
Verification Date
July 2020