CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

NCT03699345 | Completed FDA Device

• 1 other identifier: 2017-07
• Study Type: observational
• Target: 87
• Locations: 6 countries
• Sites: 11

Brief Summary

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Conditions

Aortic Valve Stenosis

Keywords

CENTERA; THV; Transcatheter Heart Valve

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  All-cause mortality at 30 days

  30 days

Study Arms (1)

Edwards CENTERA THV

Device: Transcatheter Aortic Valve Replacement (TAVR)

Interventions

Transcatheter Aortic Valve Replacement (TAVR) DEVICE

TAVR with the Edwards CENTERA THV System and accessories

Edwards CENTERA THV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

You may qualify if:

• Severe native valve calcific aortic stenosis
• Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

You may not qualify if:

• Known hypersensitivity to Nitinol (nickel or titanium)
• Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
• Inability to tolerate anticoagulation/antiplatelet therapy

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (11)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Clinique Pasteur Toulouse

Toulouse, 31076, France

Location

Johannes Gutenberg Universitaet Mainz

Mainz, 55131, Germany

Location

Deutsches Herzzentrum Muenchen (DHM)

München, 80636, Germany

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Vall d'Hebron University Hospital - Barcelona

Barcelona, 08035, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Brighton and Sussex University Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Royal Victoria Hospital Belfast

Belfast, BT12 6BA, United Kingdom

Location

Queen Elisabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Prof. Hermann Reichenspurner

  UKE Hamburg-Eppendorf - University Heart Center

  PRINCIPAL INVESTIGATOR

• Prof.Dr. Stephan Windecker

  Inselspital, Klinik für Kardiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: January 7, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 20, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); FR (1); ES (2); GB (4); NL (1); DK (1)