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Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531374
First Posted: February 10, 2012
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular
Results First Submitted: September 1, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Severe Aortic Stenosis
Intervention: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 21, 2012 and April 15, 2014, 1658 subjects were enrolled in the Continued Access Extreme Risk Study at 45 centers in the US. Between October 19, 2012 and August 12, 2014, 1119 subjects were enrolled in the High Risk Study at the same 45 US centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Extreme Risk: Iliofemoral

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Extreme Risk: Non-Iliofemoral

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

High Risk

High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)


Participant Flow:   Overall Study
    Extreme Risk: Iliofemoral   Extreme Risk: Non-Iliofemoral   High Risk
STARTED   1285   373   1119 
COMPLETED   921   231   836 
NOT COMPLETED   364   142   283 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 1658 Extreme Risk subjects were enrolled; 1257 Iliofemoral and 367 Non-Iliofemoral had an attempted implant procedure. A total of 1119 High Risk subjects were enrolled; however, 1108 subjects had an attempted implant procedure. The baseline data presented are for subjects with an attempted implant.

Reporting Groups
  Description
Extreme Risk: Iliofemoral

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Extreme Risk: Non-Iliofemoral

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

High Risk

High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Total Total of all reporting groups

Baseline Measures
   Extreme Risk: Iliofemoral   Extreme Risk: Non-Iliofemoral   High Risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 1257   367   1108   2732 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 83.5  (8.1)   81.9  (8.2)   83.6  (7.1)   83.3  (7.7) 
[1] Participant Population= Consisted of all subjects with an attempted implant procedure.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Female      568  45.2%      185  50.4%      456  41.2%      1209  44.3% 
Male      689  54.8%      182  49.6%      652  58.8%      1523  55.7% 
[1] Participant Population= Consisted of all subjects with an attempted implant procedure.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      37   2.9%      4   1.1%      38   3.4%      79   2.9% 
Not Hispanic or Latino      1206  95.9%      360  98.1%      1056  95.3%      2622  96.0% 
Unknown or Not Reported      14   1.1%      3   0.8%      14   1.3%      31   1.1% 
[1] Participant Population= Consisted of all subjects with an attempted implant procedure.
Body Surface Area [1] 
[Units: M^2]
Mean (Standard Deviation)
 1.9  (0.3)   1.8  (0.3)   1.9  (0.2)   1.9  (0.3) 
[1] Participant Population= Consisted of all subjects with an attempted implant procedure.
New York Heart Association (NYHA) Classification [1] 
[Units: Participants]
       
NYHA Classification I   0   0   0   0 
NYHA Classification II   159   45   180   384 
NYHA Classification III   881   248   811   1940 
NYHA Classification IV   217   74   117   408 
[1]

NYHA Classification:

Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Society of Thoracic Surgeons (STS) Risk Score [1] 
[Units: Percent of predicted mortality]
Mean (Standard Deviation)
 9.1  (5.1)   10.2  (5.6)   7.7  (3.3)   8.7  (4.6) 
[1] The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.
Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) [1] 
[Units: Percent of predicted mortality]
Mean (Standard Deviation)
 24.2  (17.1)   24.2  (17.1)   20.3  (13.5)   22.6  (15.9) 
[1] The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality   [ Time Frame: 1 year ]

2.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

3.  Secondary:   The Occurrence of Individual MACCE Components   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

4.  Secondary:   Major Adverse Events (MAEs)   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

5.  Secondary:   Conduction Disturbance Requiring Permanent Pacemaker Implantation   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

6.  Secondary:   Change From Baseline in NYHA Class   [ Time Frame: Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

7.  Secondary:   Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)   [ Time Frame: Baseline to 30 days, baseline to 1 year ]

8.  Secondary:   Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive   [ Time Frame: 1 year ]

9.  Secondary:   Quality of Life (QoL) Change   [ Time Frame: 30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

10.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

11.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

12.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

13.  Secondary:   Aortic Valve Hospitalizations   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

14.  Secondary:   Cardiovascular Deaths and Valve-Related Deaths   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

15.  Secondary:   Strokes and Transient Ischemic Attacks (TIAs)   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]

16.  Secondary:   Index Procedure Related MAEs   [ Time Frame: Procedure ]

17.  Secondary:   Length of Index Procedure Hospital Stay   [ Time Frame: Number of days from admission to discharge ]

18.  Secondary:   Device Success   [ Time Frame: Number of days from admission to discharge ]

19.  Secondary:   Procedural Success   [ Time Frame: Number of days from admission to discharge ]

20.  Secondary:   Prosthetic Valve Dysfunction (PVD)   [ Time Frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hatice Bilgic Lim
Organization: Medtronic, Inc.
e-mail: rs.medtroniccardiovascularclinicaltrials@medtronic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01531374     History of Changes
Other Study ID Numbers: 10037989DOC REV 1C
First Submitted: February 3, 2012
First Posted: February 10, 2012
Results First Submitted: September 1, 2016
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017