SAPIEN 3 Ultra System PMCF

Active, not recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT04555967
• Lead Sponsor: Edwards Lifesciences

Brief Summary

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Detailed Description

To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Study Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Primary Completion: 2021-09-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device success per VARC-3, defined as meeting all of the following:	30 days	* Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; * Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)

Secondary Outcome Measures

Name	Time	Method
Life threatening bleeding	30 days
Stroke	30 days and 1 year
Paravalvular leak	30 days and 1 year
Major vascular complications	30 days
Rehospitalization (valve-related or due to worsening heart failure)	1 year
New conduction defects requiring permanent pacemaker	30 days
New onset atrial fibrillation	30 days
Acute kidney injury stage 2-3	7 days
Death	1 year
Mean aortic valve gradient	30 days and 1 year

Trial Locations

Locations (11)

Medizinische Universitaet Wien; 🇦🇹 Wien, Austria

St. Paul's Hospital Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitares Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Ospedale G. Pasquinucci; 🇮🇹 Massa, Italy

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Royal Victoria Hospital Belfast; 🇬🇧 Belfast, United Kingdom

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