Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Edwards Lifesciences29 sites in 1 country934 target enrollmentSeptember 26, 2012

ConditionsAortic Valve Stenosis Aortic Valve Stenosis With Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Edwards Lifesciences
Enrollment: 934
Locations: 29
Primary Endpoint: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Detailed Description

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.

Registry

clinicaltrials.gov

Start Date

September 26, 2012

End Date

May 26, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
•Male or female, age 18 years or older
•Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation
•Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
•Provide written informed consent
•Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Exclusion Criteria

•Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
•Pure aortic insufficiency
•Requires emergency surgery
•Previous aortic valve replacement
•Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
•Requires multiple valve replacement/repair
•Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
•Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
•Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
•Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery

Outcomes

Primary Outcomes

Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort

Time Frame: Events occurring ≥ 31 days and up through 8 years post-implant

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]

Secondary Outcomes

Average Amount of Time Subject Spent on Cardiopulmonary Bypass(Day of procedure)
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)(Day of procedure through discharge from the hospital)
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success(Day of procedure)
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success(Day of procedure through discharge or 10 days post index procedure, whichever comes first.)
Subject's Performance Index Measurement Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)
Average Subject Time on Cardiopulmonary Cross Clamp(Day of procedure)
Subject's Effective Orifice Area (EOA) Measurement Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)
Subject's New York Heart Association (NYHA) Classification Over Time(Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years)
Subject's Average Mean Gradient Measurements Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up)
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)
Subject's Cardiac Index Measurement Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)
Subject's Average Peak Gradient Measurements Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up)
Subject's Cardiac Output Measurement at Over Time(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size(Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up)