NCT01675596

Brief Summary

The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

11 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

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

August 28, 2012

Results QC Date

February 15, 2019

Last Update Submit

March 25, 2019

Conditions

Severe, Symptomatic Aortic Stenosis

Keywords

Aortic StenosisTransfemoralTranscatheter Heart Valve

Outcome Measures

Primary Outcomes (1)

  • VARC-2 Composite Safety Endpoint

    The primary endpoint is a VARC-2 Composite. It comprises of 1. All cause mortality 2. All stroke 3. Life-threatening bleeding 4. Acute kidney injury - Stage 3 (including renal replacement therapy) 5. Coronary artery obstruction requiring intervention 6. Major vascular complications 7. Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.

    30 days

Secondary Outcomes (2)

  • All Cause Mortality

    30 days

  • All Cause Mortality

    12 months

Study Arms (1)

Test

EXPERIMENTAL

SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Interventions

TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDEVICE

Operable subjects

Also known as: Implantation of the Transcatheter Aortic Valve Prosthesis
Test

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 70 years
  • STS Score \> 4
  • Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

You may not qualify if:

  • Age \<70 years
  • Evidence of an acute myocardial infarction ≤ 30 days
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Stroke or transient ischemic attack (TIA) within 6 months of the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Macquarie Unversity Hospital

Macquarie Park, New South Wales, 2109, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

St Vincent's Hospital - MELBOURNE

Melbourne, Victoria, 3065, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Royal Perth Hospital/Fiona Stanley Hospital

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Tenley Koepnick
Organization
Edwards Lifesciences
tenley.koepnick@edwards.com

Study Officials

  • Dr. Owen Christopher Raffel

    The Prince Charles Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

August 28, 2012

First Posted

August 30, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2016

Study Completion

August 8, 2018

Last Updated

April 16, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(11)