SAPIEN 3 Ultra EU PMS

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04860752
• Collaborator: (none)
• Enrollment: 500
• Locations: 16
• Anticipated Duration (Months): 31.4
• Patients Per Site: 31.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis; Aortic Valve Stenosis	Device: Transcatheter Aortic Valve Implantation (TAVI)

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SAPIEN 3 Ultra EU Post-Market Observational Study
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Length of index hospitalization [Discharge, expected to be within 1-5 days post-procedure]

   Number of days in hospital after the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3	St. Poelten		Austria	3100
2	Medizinische Universitaet Vienna	Vienna		Austria	1090
3	Helsinki University Hospital	Helsinki		Finland	00100
4	UKSH University Hospital Kiel	Kiel		Germany	24105
5	Hospital Universitaet Mainz	Mainz		Germany	55131
6	Deutsches Herzzentrum Muenchen	Muenchen		Germany	80636
7	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy	80131
8	Ospedale San Camillo	Roma		Italy	00152
9	Ospedale Santissima Annunziata	Sassari		Italy	07100
10	Ospedale Mauriziano	Torino		Italy	10128
11	Azienda ULSS2 Marca Trevigiana	Treviso		Italy	31100
12	Oslo Universitetssykehus Rikshospitalet	Oslo		Norway	0372
13	Hospital Santa Maria	Lisbon		Portugal	1649-035
14	Universitatsspital Zurich	Zürich		Switzerland	8091
15	Leeds General Infirmary	Leeds		United Kingdom	LS1 3EX
16	St Thomas' Hospital	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT04860752
• Other Study ID Numbers: 2020-02
• First Posted: Apr 27, 2021
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Edwards Lifesciences: Transcatheter aortic valve implantation (TAVI); SAPIEN 3 Ultra THV; Edwards Lifesciences
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Jul 18, 2022