Back to resultsSurgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)
Primary Purpose
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EDWARDS INTUITY valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery, Aortic valve stenosis, Aortic valve regurgitation, Bovine pericardium
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 replace-ment 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
- Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
- Hyperparathyroidism
- MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
- Presence of non-cardiac disease limiting life expectancy to less than 12 months
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Left ventricular ejection fraction ≤ 25%
- Documented history of substance (drug or alcohol) abuse within the last 5 years
- Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
- Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
- Pregnancy, lactation, or planning to become pregnant;
- Currently incarcerated or unable to give voluntary informed consent
- Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
- History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
- Intra-operative Exclusion Criteria
Anatomic variances which contraindicate implant of the trial valve, such as:
- anomalous coronary arteries
- annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
- significant calcium on the anterior mitral leaflet
- pronounced septal calcification
- position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
- Available devices are not suitably sized for the subject's annulus
Sites / Locations
- Keck Hospital of University of Southern California
- University of California Los Angeles
- Hoag Memorial Hospital Presbyterian
- Stanford University
- Mercy General Hospital
- Florida Hospital
- Northwestern University
- Beth Israel Deaconess Medical Center
- The University of Michigan Medical School
- Washington University - Barnes Jewish Hospital
- Cooper University Hospital
- North Shore Long Island Jewish Health System
- New York University Medical Center
- Columbia University
- Mission Hospital
- Duke University Medical Center
- East Carolina University
- Good Samaritan Hospital
- Cleveland Clinic Foundation
- Pinnacle Health at Harrisburg Hospital
- Hospital of the University of Pennsylvania
- University of Pittsburgh Medical Center
- Baptist Memorial Hospital
- St. Thomas Health
- Medical City Dallas Hospital
- Baylor College of Medicine
- The Heart Hospital Baylor Plano
- Swedish Medical Center
- Aurora St Luke's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EDWARDS INTUITY valve
Arm Description
All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
Outcomes
Primary Outcome Measures
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
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 Outcome Measures
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Surgical and hospitalization factors - Cardiopulmonary bypass time
Average Subject Time on Cardiopulmonary Cross Clamp
Surgical and hospitalization factors - Cardiopulmonary cross clamp time
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
Subject's New York Heart Association (NYHA) Classification Over Time
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Subject's Average Mean Gradient Measurements Over Time
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Subject's Average Peak Gradient Measurements Over Time
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Subject's Effective Orifice Area (EOA) Measurement Over Time
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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Subject's Performance Index Measurement Over Time
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Subject's Cardiac Output Measurement at Over Time
Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
Subject's Cardiac Index Measurement Over Time
Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01700439
Brief Title
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
Acronym
TRANSFORM™
Official Title
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2012 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
Keywords
Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery, Aortic valve stenosis, Aortic valve regurgitation, Bovine pericardium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
934 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDWARDS INTUITY valve
Arm Type
Experimental
Arm Description
All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
Intervention Type
Device
Intervention Name(s)
EDWARDS INTUITY valve
Intervention Description
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
Primary Outcome Measure Information:
Title
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
Description
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]
Time Frame
Events occurring ≥ 31 days and up through 8 years post-implant
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Description
Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
Time Frame
Day of procedure
Title
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Description
Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
Time Frame
Day of procedure through discharge or 10 days post index procedure, whichever comes first.
Title
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Description
Surgical and hospitalization factors - Cardiopulmonary bypass time
Time Frame
Day of procedure
Title
Average Subject Time on Cardiopulmonary Cross Clamp
Description
Surgical and hospitalization factors - Cardiopulmonary cross clamp time
Time Frame
Day of procedure
Title
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Description
Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
Time Frame
Day of procedure through discharge from the hospital
Title
Subject's New York Heart Association (NYHA) Classification Over Time
Description
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time Frame
Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
Title
Subject's Average Mean 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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Title
Subject's Average Peak Gradient Measurements Over Time
Description
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Title
Subject's Effective Orifice Area (EOA) Measurement 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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
Description
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Performance Index Measurement Over Time
Description
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Cardiac Output Measurement at Over Time
Description
Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Cardiac Index Measurement Over Time
Description
Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
Description
Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Other Pre-specified Outcome Measures:
Title
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Description
The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.
Time Frame
Baseline and one year follow-up
Title
Subject's Average White Blood Cell Count Over Time
Description
Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Average Red Blood Cell Count Over Time
Description
The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Average Hematocrit Percentage Over Time
Description
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Average Hemoglobin Percentage Over Time
Description
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Title
Subject's Average Plasma Free Hemoglobin Over Time
Description
Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.
Time Frame
Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
Hyperparathyroidism
MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
Presence of non-cardiac disease limiting life expectancy to less than 12 months
Hypertrophic obstructive cardiomyopathy (HOCM)
Left ventricular ejection fraction ≤ 25%
Documented history of substance (drug or alcohol) abuse within the last 5 years
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
Pregnancy, lactation, or planning to become pregnant;
Currently incarcerated or unable to give voluntary informed consent
Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
Intra-operative Exclusion Criteria
Anatomic variances which contraindicate implant of the trial valve, such as:
anomalous coronary arteries
annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
significant calcium on the anterior mitral leaflet
pronounced septal calcification
position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
Available devices are not suitably sized for the subject's annulus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Barnhart, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Randolph Chitwood, MD
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Hospital of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The University of Michigan Medical School
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University - Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17010
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
St. Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Aurora St Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Citations:
PubMed Identifier
27817951
Citation
Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
Results Reference
result
PubMed Identifier
29705366
Citation
Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.
Results Reference
result
Links:
URL
https://manual.jointcommission.org/releases/TJC2016A/DataElem0439.html
Description
New York Heart Association Classification
Learn more about this trial
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
We'll reach out to this number within 24 hrs