NCT01808274

Brief Summary

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2013

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

March 7, 2013

Last Update Submit

November 16, 2018

Conditions

Aortic Valve Disease

Keywords

Transcatheter Aortic Valve ReplacementAortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality rate

    NAP

    30 days post-index procedure

Secondary Outcomes (2)

  • device success

    30 days

  • device success

    1 year

Study Arms (1)

TAVR

EXPERIMENTAL

with CENTERA self-expanding valve

Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve

Interventions

Edwards CENTERA Self-Expanding Transcatheter Heart ValveDEVICE

The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Also known as: TAVR, TAVI
TAVR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
  • NYHA ≥ II.
  • Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
  • Study patient is an adult of legal consent age.
  • Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

You may not qualify if:

  • Acute myocardial infarction ≤ 30 days before the intended treatment.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve.
  • Mixed aortic valve disease (with predominant aortic regurgitation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Herzzentrum Universitaet Bonn

Bonn, 53127, Germany

Location

Asklepios Klinik St Georg Hamburg

Hamburg, 20099, Germany

Location

Heart Center Leipzig

Leipzig, 042 89, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Prof. Windecker, MD

    Inselspital Bern (Switzerland)

    PRINCIPAL INVESTIGATOR

  • Prof. Mohr, MD

    Leipzig, Rhön Herzentrum (Germany)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 11, 2013

Study Start

February 1, 2013

Primary Completion

September 17, 2013

Study Completion

August 23, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)CH(1)