TRITON: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01445171
• Collaborator: (none)
• Enrollment: 295
• Locations: 6
• Arm: 1
• Duration (Months): 95
• Patients Per Site: 49.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis With Insufficiency; Aortic Valve Stenosis	Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System	N/A

Detailed Description

This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Study Design

• Study Type: Interventional
• Actual Enrollment: 295 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Study Valve Subjects act as own control	Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System; Aortic Valve bioprosthesis

Outcome Measures

Primary Outcome Measures

1. Percent of Early Adverse Events [Events occuring within 30 days of procedure]

   Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.

2. Percent of Late Adverse Events [Events occurring >= 31 days and up through 5 years post-implant]

   Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Other Outcome Measures

1. Number of Subject's With Device Technical Success [At time of surgery, an average of 3 hours]

   Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.

2. Number of Subject's With Procedural Success [Discharge(an average of 13 days) or 10 days post-implant, whichever comes first]

   Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.

3. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

4. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [Baseline, 3 Months, and 1 Year post-implant]

   The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

5. Subject's Average Mean Systolic Gradient Measurements Over Time. [Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant]

   Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

6. Subject's Average Effective Orifice Area Measurements Over Time. [Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant]

   Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

7. Subject's Amount of Aortic Valvular Regurgitation Over Time [Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant]

   Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

8. Subject's Average White Blood Cell Count Measurement Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

   Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

9. Subject's Average Red Blood Cells Count Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

   Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

10. Subject's Average Hemoglobin Count Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

11. Subject's Average Hematocrit Percentage Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.

12. Subject's Average Platelet Count Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

13. Subject's Average Reticulocytes Percentage Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.

14. Subject's Average Haptoglobin Measurement Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.

15. Subject's Average Serum LDH Measurement Over Time. [Baseline, 3 Months, 1 Year, and 5 Years post-implant]

    The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna	Vienna		Austria	1090
2	Kerchoff Klinik-Bad Nauheim	Bad Nauheim		Germany	61231
3	MHH-Medizinische Hoschschule Hannover	Hannover		Germany	30625
4	Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie	Koeln		Germany	50937
5	University Leipzig: Herzzentrum Leipzig Gmbh	Leipzig		Germany	04289
6	Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich	Munich		Germany	81377

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Study Director: Prof Axel Haverich, MHH Hannover

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 15, 2011

More Information

Additional Information:

• New York Heart Association Classification
• Measure of Health Status Survey (EQ-5D)

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01445171
• Other Study ID Numbers: 2009-01
• First Posted: Oct 3, 2011
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Edwards Lifesciences: Aortic Valve Replacement
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Period Title: Overall Study
STARTED	295
Implanted With Study Device	287
COMPLETED	200
NOT COMPLETED	95

Baseline Characteristics

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Overall Participants	287
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.3 (6.7)
Sex: Female, Male (Count of Participants)
Female	141 49.1%
Male	146 50.9%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Percent of Early Adverse Events
Description	Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Time Frame	Events occuring within 30 days of procedure

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
All Cause Mortality	1.7
Trial Valve Related Mortality	1.0
Thromboembolism	4.5
Valve Thrombosis	0.0
Major Bleeding	7.3
All Paravalvular Leak (OPC)	1.0
Hemolysis	0.7
Endocarditis	0.0
Structural Valve Deterioration	0.0
Reoperation	1.4
Explant	1.4
Valve Related AE	3.1

2. Primary Outcome

Title	Percent of Late Adverse Events
Description	Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time Frame	Events occurring >= 31 days and up through 5 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
All Cause Mortality	3.8
Trial Valve Related Mortality	0.4
Thromboembolism	1.9
Valve Thrombosis	0.0
Major Bleeding	2.1
All Paravalvular Leak (OPC)	0.6
Hemolysis	0.2
Endocarditis	0.3
Structural Valve Deterioration	0.5
Reoperation	0.5
Explant	0.5
Valve Related AE	1.0

3. Other Pre-specified Outcome

Title	Number of Subject's With Device Technical Success
Description	Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.
Time Frame	At time of surgery, an average of 3 hours

Outcome Measure Data

Analysis Population Description

This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	295
Count of Participants [Participants]	287 100%

4. Other Pre-specified Outcome

Title	Number of Subject's With Procedural Success
Description	Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.
Time Frame	Discharge(an average of 13 days) or 10 days post-implant, whichever comes first

Outcome Measure Data

Analysis Population Description

This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	295
Count of Participants [Participants]	277 96.5%

5. Other Pre-specified Outcome

Title	Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time Frame	1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	283
Improved	121 42.2%
Same	59 20.6%
Worsened	14 4.9%
Improved	189 65.9%
Same	65 22.6%
Worsened	8 2.8%
Improved	191 66.6%
Same	57 19.9%
Worsened	7 2.4%
Improved	180 62.7%
Same	46 16%
Worsened	12 4.2%
Improved	157 54.7%
Same	56 19.5%
Worsened	12 4.2%
Improved	137 47.7%
Same	60 20.9%
Worsened	10 3.5%
Improved	125 43.6%
Same	52 18.1%
Worsened	16 5.6%

6. Other Pre-specified Outcome

Title	Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Description	The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time Frame	Baseline, 3 Months, and 1 Year post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	Baseline and 3 Months Follow-Up	Baseline and 1 Year Follow-Up
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	124	250
Baseline	0.79 (0.20)	0.79 (0.19)
Follow-Up	0.87 (0.18)	0.83 (0.22)

7. Other Pre-specified Outcome

Title	Subject's Average Mean Systolic Gradient Measurements Over Time.
Description	Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time Frame	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Discharge	10.6 (4.2)
1 Month	9.5 (2.8)
3 Months	9.0 (3.4)
1 Year	9.0 (3.5)
2 Years	8.8 (3.0)
3 Years	9.6 (4.3)
4 Years	10.0 (4.7)
5 Years	9.9 (5.1)

8. Other Pre-specified Outcome

Title	Subject's Average Effective Orifice Area Measurements Over Time.
Description	Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time Frame	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Discharge	1.7 (0.2)
1 Month	1.6 (0.2)
3 Months	1.7 (0.2)
1 Year	1.7 (0.2)
2 Years	1.7 (0.2)
3 Years	1.7 (0.2)
4 Years	1.7 (0.3)
5 Years	1.7 (0.3)

9. Other Pre-specified Outcome

Title	Subject's Amount of Aortic Valvular Regurgitation Over Time
Description	Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time Frame	Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
0 None/+1 Trivial	244 85%
+2 Mild	10 3.5%
+3 Moderate	2 0.7%
+4 Severe	1 0.3%
0 None/+1 Trivial	10 3.5%
+2 Mild	1 0.3%
+3 Moderate	0 0%
+4 Severe	0 0%
0 None/+1 Trivial	235 81.9%
+2 Mild	11 3.8%
+3 Moderate	4 1.4%
+4 Severe	1 0.3%
0 None/+1 Trivial	231 80.5%
+2 Mild	14 4.9%
+3 Moderate	3 1%
+4 Severe	0 0%
0 None/+1 Trivial	86 30%
+2 Mild	7 2.4%
+3 Moderate	4 1.4%
+4 Severe	0 0%
0 None/+1 Trivial	177 61.7%
+2 Mild	12 4.2%
+3 Moderate	4 1.4%
+4 Severe	0 0%
0 None/+1 Trivial	125 43.6%
+2 Mild	11 3.8%
+3 Moderate	4 1.4%
+4 Severe	0 0%
0 None/+1 Trivial	161 56.1%
+2 Mild	9 3.1%
+3 Moderate	4 1.4%
+4 Severe	0 0%

10. Other Pre-specified Outcome

Title	Subject's Average White Blood Cell Count Measurement Over Time.
Description	Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	6.80 (2.0)
3 Months	6.97 (1.8)
1 Year	7.10 (2.0)
5 Years	7.31 (2.0)

11. Other Pre-specified Outcome

Title	Subject's Average Red Blood Cells Count Over Time.
Description	Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	4.30 (0.5)
3 Months	4.40 (0.5)
1 Year	4.36 (0.5)
5 Years	4.35 (0.8)

12. Other Pre-specified Outcome

Title	Subject's Average Hemoglobin Count Over Time.
Description	Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	12.87 (1.7)
3 Months	12.49 (1.4)
1 Year	13.00 (1.5)
5 Years	13.16 (1.6)

13. Other Pre-specified Outcome

Title	Subject's Average Hematocrit Percentage Over Time.
Description	Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	38.29 (4.7)
3 Months	38.07 (4.1)
1 Year	38.93 (4.1)
5 Years	39.58 (4.4)

14. Other Pre-specified Outcome

Title	Subject's Average Platelet Count Over Time.
Description	Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	220.33 (66.30)
3 Months	223.07 (59.70)
1 Year	213.22 (60.40)
5 Years	206.85 (63.5)

15. Other Pre-specified Outcome

Title	Subject's Average Reticulocytes Percentage Over Time.
Description	Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	2.13 (2.5)
3 Months	1.59 (1.9)
1 Year	2.07 (5.0)
5 Years	1.82 (2.2)

16. Other Pre-specified Outcome

Title	Subject's Average Haptoglobin Measurement Over Time.
Description	Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	63.08 (69.50)
3 Months	82.15 (81.10)
1 Year	80.65 (80.50)
5 Years	79.36 (81.20)

17. Other Pre-specified Outcome

Title	Subject's Average Serum LDH Measurement Over Time.
Description	The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Time Frame	Baseline, 3 Months, 1 Year, and 5 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.

Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
Measure Participants	287
Baseline	223.91 (53.0)
3 Months	271.37 (87.20)
1 Year	250.56 (76.20)
5 Years	254.46 (76.30)

Adverse Events

Time Frame	Events occurring from baseline through five years post-implant
Adverse Event Reporting Description	The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
Arm/Group Title	INTUITY Aortic Valve and INTUITY Delivery System
Arm/Group Description	The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
All Cause Mortality
	INTUITY Aortic Valve and INTUITY Delivery System
	Affected / at Risk (%)	# Events
Total	51/287 (17.8%)
Serious Adverse Events
	INTUITY Aortic Valve and INTUITY Delivery System
	Affected / at Risk (%)	# Events
Total	233/287 (81.2%)
Blood and lymphatic system disorders
Bleeding - Gastrointestinal	10/287 (3.5%)	13
Bleeding - Post-Procedural	12/287 (4.2%)	12
Bleeding - Other	11/287 (3.8%)	12
Bleeding - Anticoagulant Related	4/287 (1.4%)	4
Bleeding - Hematoma	4/287 (1.4%)	4
Bleeding - Pericardial Tamponade	4/287 (1.4%)	4
Bleeding - Hemolysis	2/287 (0.7%)	2
Bleeding - Procedural	2/287 (0.7%)	2
Embolic Event - Other	2/287 (0.7%)	2
Bleeding - Intracranial	1/287 (0.3%)	1
Cardiac disorders
Cardiac - Other	32/287 (11.1%)	35
Cardiac - Atrial Fibrillation	32/287 (11.1%)	32
Cardiac - Heart Failure	20/287 (7%)	26
Cardiac - Other Arrhythmia	18/287 (6.3%)	18
Cardiac - AV Block III	17/287 (5.9%)	17
Embolic Event - Stroke	16/287 (5.6%)	17
Cardiac - Hypertension	11/287 (3.8%)	11
Cardiac - Atrial Flutter	8/287 (2.8%)	8
Cardiac - Pericardial Effusion	8/287 (2.8%)	8
Embolic Event - TIA	7/287 (2.4%)	7
Cardiac - Cardiac Arrest	6/287 (2.1%)	6
Cardiac - Myocardial Infarction	6/287 (2.1%)	6
Cardiac - Angina, Stable	5/287 (1.7%)	6
Cardiac - Angina, Unstable	4/287 (1.4%)	5
Cardiac - Bradycardia	4/287 (1.4%)	4
Vascular - Deep Vein Thrombosis (DVT)	4/287 (1.4%)	4
Cardiac - Hypotension	2/287 (0.7%)	2
Cardiac - Supraventricular Tachycardia (SVT)	2/287 (0.7%)	2
Valvular - Paravalvular Leak - Moderate	2/287 (0.7%)	2
Cardiac - Aortic Dissection - Type A	1/287 (0.3%)	1
Cardiac - Aortic Dissection - Type B	1/287 (0.3%)	1
Cardiac - AV Block II	1/287 (0.3%)	1
Cardiac - Cardiogenic Shock	1/287 (0.3%)	1
Cardiac - Pericardial Tamponade	1/287 (0.3%)	1
Cardiac - Ventricular Fibrillation	1/287 (0.3%)	1
Embolic Event - Peripheral Embolic Event	1/287 (0.3%)	1
Valvular - Aortic Regurgitation - Moderate-Severe	1/287 (0.3%)	1
Valvular - Mitral Regurgitation - Mild-Moderate	1/287 (0.3%)	1
Valvular - Mitral Regurgitation - Moderate-Severe	1/287 (0.3%)	1
Valvular - Other Mitral Valve	1/287 (0.3%)	1
Valvular - Paravalvular Leak - Mild	1/287 (0.3%)	1
Vascular - Vascular Access Site Complication	1/287 (0.3%)	1
Gastrointestinal disorders
Gastrointestinal - Other	26/287 (9.1%)	34
General disorders
Other	137/287 (47.7%)	206
Other - Anemia	25/287 (8.7%)	27
Other - Allergic Reaction	4/287 (1.4%)	4
Multisystem Organ Failure	2/287 (0.7%)	2
Hepatobiliary disorders
Hepatic - Other	2/287 (0.7%)	2
Hepatic - Liver Failure	1/287 (0.3%)	1
Infections and infestations
Infection - Other	37/287 (12.9%)	45
Infection - Local	16/287 (5.6%)	17
Infection - Pneumonia	16/287 (5.6%)	17
Infection - Sternal Wound Infection	5/287 (1.7%)	7
Infection - Sepsis/Septicemia	6/287 (2.1%)	6
Infection - Bacteremia	5/287 (1.7%)	5
Infection - Endocarditis (Aortic Valve)	3/287 (1%)	3
Infection - Endocarditis (Mitral Valve)	1/287 (0.3%)	1
Infection - Systemic	1/287 (0.3%)	1
Renal and urinary disorders
Renal - Renal Failure	13/287 (4.5%)	14
Renal - Renal Dysfunction	9/287 (3.1%)	9
Renal - Other	5/287 (1.7%)	5
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion	57/287 (19.9%)	60
Pulmonary - Other	9/287 (3.1%)	13
Pulmonary - Respiratory Dysfunction/Insufficiency	9/287 (3.1%)	10
Pulmonary - Respiratory Failure	4/287 (1.4%)	6
Pulmonary - Pneumothorax	5/287 (1.7%)	5
Embolic Event - Pulmonary Embolism	2/287 (0.7%)	2
Pulmonary - Atelectasis	1/287 (0.3%)	1
Pulmonary - Pulmonary Edema	1/287 (0.3%)	1
Pulmonary - Pulmonary Hypertension	1/287 (0.3%)	1
Vascular disorders
Vascular - Other	12/287 (4.2%)	14
Other (Not Including Serious) Adverse Events
	INTUITY Aortic Valve and INTUITY Delivery System
	Affected / at Risk (%)	# Events
Total	189/287 (65.9%)
Blood and lymphatic system disorders
Bleeding - Hematoma	4/287 (1.4%)	4
Bleeding - Other	4/287 (1.4%)	4
Bleeding - Anticoagulant Related	3/287 (1%)	3
Bleeding - Gastrointestinal	2/287 (0.7%)	2
Embolic Event - Other	2/287 (0.7%)	2
Embolic Event - Stroke	2/287 (0.7%)	2
Embolic Event - TIA	2/287 (0.7%)	2
Bleeding - Hemolysis	1/287 (0.3%)	1
Bleeding - Heparin Induced Thrombocytopenia (HITS)	1/287 (0.3%)	1
Embolic Event - Peripheral Embolic Event	1/287 (0.3%)	1
Cardiac disorders
Cardiac - Atrial Fibrillation	43/287 (15%)	43
Cardiac - BBB - Left Complete	9/287 (3.1%)	9
Valvular - Mitral Regurgitation - Mild	9/287 (3.1%)	9
Cardiac - Other	8/287 (2.8%)	8
Cardiac - BBB - Left Partial	7/287 (2.4%)	7
Cardiac - Other Arrhythmia	7/287 (2.4%)	7
Cardiac - Atrial Flutter	6/287 (2.1%)	6
Valvular - Aortic Regurgitation - Mild	5/287 (1.7%)	5
Cardiac - BBB - Right Complete	4/287 (1.4%)	4
Vascular - Deep Vein Thrombosis (DVT)	4/287 (1.4%)	4
Cardiac - AV Block I	3/287 (1%)	3
Cardiac - Bradycardia	3/287 (1%)	3
Cardiac - Hypertension	3/287 (1%)	3
Cardiac - Ventricular Tachycardia	3/287 (1%)	3
Valvular - Aortic Stenosis - Moderate	3/287 (1%)	3
Cardiac - AV Block III	2/287 (0.7%)	2
Cardiac - Pericardial Effusion	2/287 (0.7%)	2
Cardiac - Angina, Stable	1/287 (0.3%)	1
Cardiac - Heart Failure	1/287 (0.3%)	1
Cardiac - Hypotension	1/287 (0.3%)	1
Cardiac - Supraventricular Tachycardia (SVT)	1/287 (0.3%)	1
Valvular - Aortic Regurgitation - Mild-Moderate	1/287 (0.3%)	1
Valvular - Aortic Stenosis - Mild	1/287 (0.3%)	1
Valvular - Aortic Stenosis - Severe	1/287 (0.3%)	1
Valvular - Mitral Regurgitation - Moderate-Severe	1/287 (0.3%)	1
Valvular - Other Mitral Valve	1/287 (0.3%)	1
Valvular - Other Tricuspid Valve	1/287 (0.3%)	1
Valvular - Paravalvular Leak - Mild/Moderate	1/287 (0.3%)	1
Valvular - Paravalvular Leak - Moderate	1/287 (0.3%)	1
Valvular - Paravalvular Leak - Trace/Trivial	1/287 (0.3%)	1
Valvular - Structural Deterioration	1/287 (0.3%)	1
Valvular - Tricuspid Regurgitation	1/287 (0.3%)	1
Vascular - Other	1/287 (0.3%)	1
Gastrointestinal disorders
Gastrointestinal - Other	12/287 (4.2%)	17
Hepatic - Other	3/287 (1%)	3
General disorders
Other	85/287 (29.6%)	128
Other - Anemia	11/287 (3.8%)	11
Other - Allergic Reaction	3/287 (1%)	4
Infections and infestations
Infection - Other	45/287 (15.7%)	50
Infection - Local	13/287 (4.5%)	14
Infection - Pneumonia	7/287 (2.4%)	7
Infection - Sternal Wound Infection	6/287 (2.1%)	6
Infection - Bacteremia	4/287 (1.4%)	4
Infection - Systemic	1/287 (0.3%)	1
Renal and urinary disorders
Renal - Renal Dysfunction	9/287 (3.1%)	9
Renal - Other	5/287 (1.7%)	5
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion	16/287 (5.6%)	16
Pulmonary - Other	7/287 (2.4%)	7
Pulmonary - Pneumothorax	1/287 (0.3%)	1
Pulmonary - Pulmonary Hypertension	1/287 (0.3%)	1
Pulmonary - Respiratory Dysfunction/Insufficiency	1/287 (0.3%)	1
Pulmonary - Respiratory Failure	1/287 (0.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 60 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 90 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.