Back to resultsEDWARDS INTUITY Valve System CADENCE-MIS Study (CADENCE-MIS)
Primary Purpose
Aortic Valve Disease, Aortic Stenosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EDWARDS INTUITY Valve System, Model 8300A
Stented Aortic Bioprostheses
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease focused on measuring Aortic Valve Replacement, Minimal Invasive Sternotomy
Eligibility Criteria
Inclusion:
- adult male or female ≥18 years of age
- symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
- EuroSCORE <20
- NYHA Class ≥II
- Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
- Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
Exclusion (i.a.):
- pure aortic insufficiency
- previous cardiac surgery (involved FS or MIS approach)
- congenital true bicuspid / unicuspid aortic valve
requires emergency surgery or has had emergency surgery for any reason
≤ 1 month before the intended treatment
- LVEF <25%
- active endocarditis ≤ 6 months before the intended treatment
- acute MI ≤ 90 days before the intended treatment
- had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
- oxygen or ventilator dependent
- life expectancy < 12 months
- substance abuser
- Female subject is pregnant or lactating
- documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy
- hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
- documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
- 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
- currently participating in an investigational drug or device trial for which follow-up has not yet been completed
- Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition
Intra-operative Exclusion:
- has calcium on the anterior mitral leaflet which cannot be removed
- has extensive calcification of the aortic root
- Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
- has left atrial thrombus
- The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
- hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
- Study device is not available in the correct size for the subject
Sites / Locations
- Leipzig Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EDWARDS INTUITY
Stented Aortic Bioprostheses
Arm Description
EDWARDS INTUITY Valve System, Model 8300A
Stented Aortic Bioprostheses
Outcomes
Primary Outcome Measures
Median 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.
Median 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.
Secondary Outcome Measures
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
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 Gradients (mmHg) 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. Mean gradient values depend on the size and type of valve.
Subject's Average Peak Gradients (mmHg) 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.
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.
Amount of Paravalvular Leak Over Time.
Number of subjects who experienced a Paravalvular Leak shown over various time points.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.
Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.
Higher numbers on the scale show a worsening outcome.
Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Subjects Who Required a Thoracic Resternotomy Over Time
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Subjects Who Received a Permanent Pacemaker Over Time.
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time
Number of subjects who experienced a Paravalvular Leak shown over various time points.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.
Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.
Higher numbers on the scale show a worsening outcome.
Subjects Who Experienced Major Bleeding Over Time.
Number of subjects who experienced Major Bleeding shown over various time points.
Subjects Who Experienced Respiratory Failure Over Time
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Subjects With Renal Failure Over Time
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Subjects With Endocarditis Over Time
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Subjects With a Deep Sternal Would Infection Over Time
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Subjects With a Myocardial Infarction Over Time
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Subjects With a Thromboembolism Over Time
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Subjects With a Cardiac Tamponade Over Time
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Subjects With a Cardiac Reoperation for Any Reason Over Time
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.
Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
The EuroQol-5 Dimension (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.
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).
The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.
Health Care Utilization
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
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 aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Amount of Aortic Valvular Regurgitation Over Time.
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.
Higher numbers on the scale show a worsening outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02672553
Brief Title
EDWARDS INTUITY Valve System CADENCE-MIS Study
Acronym
CADENCE-MIS
Official Title
A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
Detailed Description
This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Stenosis
Keywords
Aortic Valve Replacement, Minimal Invasive Sternotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDWARDS INTUITY
Arm Type
Active Comparator
Arm Description
EDWARDS INTUITY Valve System, Model 8300A
Arm Title
Stented Aortic Bioprostheses
Arm Type
Active Comparator
Arm Description
Stented Aortic Bioprostheses
Intervention Type
Device
Intervention Name(s)
EDWARDS INTUITY Valve System, Model 8300A
Other Intervention Name(s)
aortic stenosis, stenosis-based insufficiency, aortic valve replacement
Intervention Description
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.
Intervention Type
Device
Intervention Name(s)
Stented Aortic Bioprostheses
Other Intervention Name(s)
aortic stenosis, stenosis-based insufficiency, aortic valve replacement
Intervention Description
In comparison to control valves available on the market undergoing FS-AVR
Primary Outcome Measure Information:
Title
Median Subject Time Spent on Cardiopulmonary Cross Clamp
Description
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.
Time Frame
At time of surgery; an average of 1 hour
Title
Median Amount of Time Subject Spent on Cardiopulmonary Bypass
Description
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Time Frame
At time of surgery; an average of 1 hour
Secondary Outcome Measure Information:
Title
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
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 and 2 Years.
Title
Subject's Average Mean Gradients (mmHg) 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
Baseline, Discharge, 30 days, 3 Months, 1 Year
Title
Subject's Average Peak Gradients (mmHg) 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.
Time Frame
Baseline, Discharge, 30 days, 3 Months, 1 Year
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.
Time Frame
Baseline, Discharge, 30 days, 3 Months, 1 Year
Title
Amount of Paravalvular Leak Over Time.
Description
Number of subjects who experienced a Paravalvular Leak shown over various time points.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.
Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.
Higher numbers on the scale show a worsening outcome.
Time Frame
Discharge, 30 days, 3 month, 1 year
Title
Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.
Description
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Time Frame
Prior to Surgery
Title
Subjects Who Required a Thoracic Resternotomy Over Time
Description
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects Who Received a Permanent Pacemaker Over Time.
Description
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time
Description
Number of subjects who experienced a Paravalvular Leak shown over various time points.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.
Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.
Higher numbers on the scale show a worsening outcome.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects Who Experienced Major Bleeding Over Time.
Description
Number of subjects who experienced Major Bleeding shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects Who Experienced Respiratory Failure Over Time
Description
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Description
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With Renal Failure Over Time
Description
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With Endocarditis Over Time
Description
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Deep Sternal Would Infection Over Time
Description
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Myocardial Infarction Over Time
Description
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Thromboembolism Over Time
Description
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Cardiac Tamponade Over Time
Description
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Subjects With a Cardiac Reoperation for Any Reason Over Time
Description
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Time Frame
30 days, 3 Months, 1 Year, 2 Years.
Title
Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.
Description
Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.
Time Frame
Prior to Surgery
Title
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
Description
The EuroQol-5 Dimension (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, 30 days, 3 Months, 1 Year
Title
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
Description
Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).
The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time Frame
Baseline, 30 days, 3 Months, 1 Year
Title
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
Description
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.
Time Frame
Baseline, 30 days, 3 Months, 1 Year
Title
Health Care Utilization
Description
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Time Frame
Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks
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 aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time Frame
Baseline, Discharge, 30 days, 3 Months, 1 Year
Title
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.
Higher numbers on the scale show a worsening outcome.
Time Frame
Discharge, 30 days, 3 month, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
adult male or female ≥18 years of age
symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
EuroSCORE <20
NYHA Class ≥II
Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
Exclusion (i.a.):
pure aortic insufficiency
previous cardiac surgery (involved FS or MIS approach)
congenital true bicuspid / unicuspid aortic valve
requires emergency surgery or has had emergency surgery for any reason
≤ 1 month before the intended treatment
LVEF <25%
active endocarditis ≤ 6 months before the intended treatment
acute MI ≤ 90 days before the intended treatment
had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
oxygen or ventilator dependent
life expectancy < 12 months
substance abuser
Female subject is pregnant or lactating
documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy
hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
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
currently participating in an investigational drug or device trial for which follow-up has not yet been completed
Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition
Intra-operative Exclusion:
has calcium on the anterior mitral leaflet which cannot be removed
has extensive calcification of the aortic root
Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
has left atrial thrombus
The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
Study device is not available in the correct size for the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Borger, MD
Organizational Affiliation
Leipzig Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leipzig Heart Center
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
As of this date no IPD plan has been formulated.
Citations:
PubMed Identifier
26935407
Citation
Borger MA, Dohmen PM, Knosalla C, Hammerschmidt R, Merk DR, Richter M, Doenst T, Conradi L, Treede H, Moustafine V, Holzhey DM, Duhay F, Strauch J. Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. Eur J Cardiothorac Surg. 2016 Oct;50(4):713-720. doi: 10.1093/ejcts/ezw042. Epub 2016 Mar 2.
Results Reference
result
PubMed Identifier
25441065
Citation
Borger MA, Moustafine V, Conradi L, Knosalla C, Richter M, Merk DR, Doenst T, Hammerschmidt R, Treede H, Dohmen P, Strauch JT. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg. 2015 Jan;99(1):17-25. doi: 10.1016/j.athoracsur.2014.09.022. Epub 2014 Nov 20.
Results Reference
result
Links:
URL
https://euroqol.org/eq-5d-instruments/
Description
EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life.
Learn more about this trial
EDWARDS INTUITY Valve System CADENCE-MIS Study
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