NCT02688153

Brief Summary

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

October 14, 2015

Results QC Date

March 12, 2018

Last Update Submit

May 30, 2018

Conditions

Aortic Valve DiseaseAortic Stenosis

Keywords

Aortic Valve ReplacementAortic StenosisEDWARDS INTUITY

Outcome Measures

Primary Outcomes (2)

  • Average Subject Time Spent on Cardiopulmonary Cross Clamp

    Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

    At time of surgery, an average of 1.5 hours

  • Average Amount of Time Subject Spent on Cardiopulmonary Bypass

    Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

    At time of surgery, an average of 2 hours

Secondary Outcomes (25)

  • Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.

    Baseline and 2 Years

  • Subject's Average Mean Gradients (mmHg) Measurements Over Time.

    30 days, 3 Months, 6 Months, 1 Year, 2 Years.

  • Subject's Average Peak Gradients (mmHg) Measurements Over Time.

    30 days, 3 months, 6 months, 1 year, 2 year

  • Subject's Effective Orifice Area (EOA) Measurement Over Time.

    30 days, 3 months, 6 months, 1 year, 2 year

  • Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.

    30 days, 3 months, 6 months, 1 year, 2 year

  • +20 more secondary outcomes

Study Arms (2)

EDWARDS INTUITY

ACTIVE COMPARATOR

EDWARDS INTUITY Valve System, Model 8300A

Device: EDWARDS INTUITY

Stented aortic bioprostheses

ACTIVE COMPARATOR

Stented aortic bioprostheses

Device: Stented aortic bioprostheses

Interventions

EDWARDS INTUITYDEVICE

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.

Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement
EDWARDS INTUITY
Stented aortic bioprosthesesDEVICE

In comparison to control valves available on the market.

Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement
Stented aortic bioprostheses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age
  • aortic stenosis / mixed aortic stenosis and aortic insufficiency
  • SAVR+CABG (1-4 distal anastomoses)
  • Log. EuroSCORE ≥6
  • NYHA Class ≥II
  • pure aortic insufficiency
  • pre-existing prosthetic heart valve or ring
  • congenital true bicuspid / unicuspid aortic valve
  • LVEF \<20%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux, Hôpital Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Results Point of Contact

Title
Mary Edwards, VP Clinical and Regulatory Affairs, HVT
Organization
Edwards Lifesciences, LLC
mary_edwards@edwards.com
949-250-2500

Study Officials

  • Prof. Labrousse, MD

    CHU Bordeaux - Hôpital Haut-Lévèque

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

February 23, 2016

Study Start

October 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 1, 2018

Results First Posted

June 1, 2018

Record last verified: 2018-05

Locations

FR(1)