SAPIEN 3 Ultra System PMCF

Aortic Valve Stenosis Clinical Trial

Official title:

SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04555967
• Other study ID #: 2018-09
• Status: Active, not recruiting
• Start date: June 30, 2020
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 2026
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs.

• Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality = 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
• Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.

2. Subject has provided written informed consent to comply with all study procedures and follow-up visits

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• SAPIEN 3 Ultra System
Transcatheter aortic valve implantation

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Wien	Wien
Canada	St. Paul's Hospital Vancouver	Vancouver	British Columbia
Denmark	Aarhus University Hospital, Skejby	Aarhus
Finland	Helsinki University Hospital	Helsinki
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitares Herzzentrum Hamburg	Hamburg
Italy	Ospedale G. Pasquinucci	Massa
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
United Kingdom	Royal Victoria Hospital Belfast	Belfast
United Kingdom	King's College Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Canada,  Denmark,  Finland,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device success per VARC-3, defined as meeting all of the following:	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)	30 days
Secondary	Death		1 year
Secondary	Stroke		30 days and 1 year
Secondary	Major vascular complications		30 days
Secondary	Life threatening bleeding		30 days
Secondary	New conduction defects requiring permanent pacemaker		30 days
Secondary	Acute kidney injury stage 2-3		7 days
Secondary	New onset atrial fibrillation		30 days
Secondary	Rehospitalization (valve-related or due to worsening heart failure)		1 year
Secondary	Paravalvular leak		30 days and 1 year
Secondary	Mean aortic valve gradient		30 days and 1 year