CENTERA PMCF: Post-Market Follow-up of the CENTERA Transc... | NCT03699345

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2019Actual

Primary Completion Date

Aug 14, 2019Actual

Completion Date

Aug 20, 2024Actual

First Submitted Date

Oct 4, 2018

First Submission Date that Met QC Criteria

Oct 4, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

A prospective, international, single arm, multi-center post market clinical follow-up study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Edwards CENTERA THV			Device: Transcatheter Aortic Valve Replacement (TAVR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Aortic Valve Replacement (TAVR)	Device	TAVR with the Edwards CENTERA THV System and accessories	Edwards CENTERA THV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-Cause Mortality	All-cause mortality at 30 days	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Hermann Reichenspurner	UKE Hamburg-Eppendorf - University Heart Center	Principal Investigator
Prof.Dr. Stephan Windecker	Inselspital, Klinik für Kardiologie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby		Aarhus		8200	Denmark
Clinique Pasteur Toulouse

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation
D019616	Thoracic Surgical Procedures