Clinical trial NCT04555967: SAPIEN 3 Ultra System PMCF
Official title: SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Replacement
SAPIEN 3 Ultra
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device success per VARC-3, defined as meeting all of the following:
timeFrame: 30 days
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Stroke
timeFrame: 30 days and 1 year
measure: Major vascular complications
timeFrame: 30 days
measure: Life threatening bleeding
timeFrame: 30 days
measure: New conduction defects requiring permanent pacemaker
timeFrame: 30 days
measure: Acute kidney injury stage 2-3
timeFrame: 7 days
measure: New onset atrial fibrillation
timeFrame: 30 days
measure: Rehospitalization (valve-related or due to worsening heart failure)
timeFrame: 1 year
measure: Paravalvular leak
timeFrame: 30 days and 1 year
measure: Mean aortic valve gradient
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Vancouver
country: Canada
facility: St. Paul's Hospital Vancouver
state: British Columbia
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: Universitares Herzzentrum Hamburg
city: Massa
country: Italy
facility: Ospedale G. Pasquinucci
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital Belfast
city: London
country: United Kingdom
facility: King's College Hospital London
Study officials:
References: