N/A
N=295
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Aortic Valve Stenosis With Insufficiency · Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01445171 ↗Enrolled (actual)
295
Serious AEs
81.2%
Results posted
Feb 2020
Primary outcome: Primary: Percent of Early Adverse Events — 1.7; 1.0; 4.5; 0.0 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aortic Valve Replacement with EDWARDS INTUITY Valve System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Early Adverse Events |
1.7; 1.0; 4.5; 0.0; 7.3; 1.0 | — |
| PRIMARY Percent of Late Adverse Events |
3.8; 0.4; 1.9; 0.0; 2.1; 0.6 | — |
Summary
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
Eligibility Criteria
Criteria:
Inclusion Criteria
- 18 years or older
- Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
- Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
- Signed and dated the informed consent form prior to investigation procedures;
- Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.
Exclusion Criteria
- Pure aortic insufficiency
- Requires emergency surgery
- Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
- Left ventricular ejection fraction of ≤ 25%
- Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis
- Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
- Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
- Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
- Disease limiting life expectancy to less than 12 months
- Pregnant or lactating
- Currently participating in another drug or device clinical investigation;
- Documented blood diatheses
- Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
- Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery
- Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
- Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
- Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
- Documented hyperparathyroidism
Data sourced from ClinicalTrials.gov (NCT01445171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.