SAPIEN 3 Ultra EU PMS

Completed

• Conditions: Aortic Valve Stenosis; Aortic Stenosis

• Registration Number: NCT04860752
• Lead Sponsor: Edwards Lifesciences

Brief Summary

This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

Detailed Description

This is a prospective, observational, single-arm, multicentre, post-market study.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Primary Completion: 2024-07-22
• Study Completion: 2024-07-22
• Results First Submitted: 2025-04-30
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Results First Posted: 2025-07-29
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
2. Less than 80 years of age at time of the procedure
3. Low surgical risk
4. Meets clinical and procedural requirements for early discharge
5. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent

Exclusion Criteria

1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
2. Considered to be part of a vulnerable population
3. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
4. Cannot tolerate an anticoagulation/antiplatelet regimen
5. Active bacterial endocarditis
6. Participating in a drug or device study that has not reached its primary endpoint

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of Index Hospitalization	Discharge from hospital, expected to be within 1-5 days post-procedure	Number of days in hospital after the procedure

Secondary Outcome Measures

Name	Time	Method
Death	1 year	Number of patients who died
Stroke	1 year	Number of patients who had a stroke
New Requirement for Permanent Pacemaker	1 year	Number of patients who received a new permanent pacemaker
Aortic Valve Reintervention	1 year	Number of patients who required valve reintervention
Aortic Regurgitation	At discharge from hospital, expected to be within 1-5 days post-procedure	Number of patients who had moderate or greater aortic regurgitation
Mean Gradient	At discharge from hospital, expected to be within 1-5 days post-procedure	Mean gradient (mmHg)
Effective Orifice Area	At discharge from hospital, expected to be within 1-5 days post-procedure	Aortic valve area (cm2)
Discharge Location	At discharge from hospital, expected to be within 1-5 days post-procedure	Number of patients who were discharged to home or self-care (routine discharge)

Trial Locations

Locations (37)

LKH-Univ. Graz Klinik, Auenbruggerplaz 15; 🇦🇹 Graz, Austria

Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3; 🇦🇹 St. Poelten, Austria

Medizinische Universitaet Vienna; 🇦🇹 Vienna, Austria

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital, Teiskontie 35; 🇫🇮 Tampere, Finland

Clinique St Augustin; 🇫🇷 Bordeaux, France

Institut Hospitalier Jacques Cartier Massy; 🇫🇷 Massy, France

CHU Bordeaux Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

CHU Hopital Charles Nicolle Rouen; 🇫🇷 Rouen, France

Hdz Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Scroll for more (27 remaining)