CompletedNot Applicable

CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

Australia, Belgium, Czechia1,001 participantsStarted 2018-10-25

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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)

What they're measuring

Cardiovascular Mortality

Timeframe: 30 days from the index procedure

Trial details

NCT IDNCT03752866

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-02

Results submitted2023-10-19

View on ClinicalTrials.gov More Symptomatic Degenerative Aortic Stenosis trials