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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01240902
First received: November 10, 2010
Last updated: April 12, 2016
Last verified: April 2016
History of Changes
Results First Received: March 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Severe Aortic Stenosis
Interventions: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Surgical Aortic Valve Replacement (SAVR)

  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 Feb 17, 2011 and Aug 23, 2013, 656 subjects were enrolled into the CoreValve US Pivotal Trial Extreme Risk study at 41 of the 43 activated centers in the United States. Between February 2, 2011 and July 23, 2013, 797 subjects were enrolled into the CoreValve US Pivotal Trial High Risk study at 45 centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first 3 successfully enrolled and implanted iliofemoral subjects at each implanting site, inclusive of both the High Risk Surgical and Extreme Risk patient populations were considered roll-in subjects, and were automatically assigned to undergo Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI).

Reporting Groups
  Description
Extreme Risk: TAVI Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Extreme Risk: TAVI Non-Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
High Risk: TAVI High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: SAVR High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Participant Flow:   Overall Study
    Extreme Risk: TAVI Iliofemoral     Extreme Risk: TAVI Non-Iliofemoral     High Risk: TAVI     High Risk: SAVR  
STARTED     500     156     395     402  
COMPLETED     289     77     295     237  
NOT COMPLETED     211     79     100     165  



  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.
Participant Population= As Treated (AT) cohort. The AT cohort consisted of all Intent to Treat (ITT) subjects with an attempted implant procedure.

Reporting Groups
  Description
Extreme Risk: TAVI Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Extreme Risk: TAVI Non-Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
High Risk: TAVI High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: SAVR High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
Total Total of all reporting groups

Baseline Measures
    Extreme Risk: TAVI Iliofemoral     Extreme Risk: TAVI Non-Iliofemoral     High Risk: TAVI     High Risk: SAVR     Total  
Number of Participants  
[units: participants]
 		  489     150     391     359     1389  
Age [1]
[units: years]
Mean (Standard Deviation) 		  83.2  (8.7)     81.3  (7.4)     83.2  (7.1)     83.3  (6.4)     83.0  (7.6)  
Gender [1]
[units: participants]
 		         
Female     255     82     184     171     692  
Male     234     68     207     188     697  
Race (NIH/OMB) [1]
[units: participants]
 		         
American Indian or Alaska Native     0     0     0     1     1  
Asian     2     1     0     1     4  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     19     5     3     11     38  
White     468     143     387     343     1341  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     1     1     2     4  
Body Surface Area [1]
[units: m^2]
Mean (Standard Deviation) 		  1.8  (0.3)     1.8  (0.2)     1.8  (0.2)     1.9  (0.2)     1.8  (0.2)  
NYHA Classification [2]
[units: participants]
 		         
NYHA I     0     0     0     0     0  
NYHA II     40     12     57     47     156  
NYHA III     313     98     255     250     916  
NYHA IV     136     40     79     62     317  
Society of Thoracic Surgeons (STS) Risk Score [3]
[units: % risk of mortality or morbidity]
Mean (Standard Deviation) 		  10.3  (5.5)     10.7  (5.7)     7.3  (3.0)     7.5  (3.3)     8.8  (4.7)  
Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) [4]
[units: %]
Mean (Standard Deviation) 		  22.6  (17.1)     22.9  (15.9)     17.7  (13.0)     18.8  (13.2)     20.3  (15.1)  
[1] Participant Population= Consisted of all subjects with an attempted implant procedure.
[2]

New York Heart Association (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.
[3] 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.
[4] 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
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1.  Primary:   Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 2

3.  Secondary:   The Occurrence of Individual MACCE Components   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 3

4.  Secondary:   Major Adverse Events (MAEs)   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 4

5.  Secondary:   Conduction Disturbance Requiring Permanent Pacemaker Implantation   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 5

6.  Secondary:   Change in NYHA Class   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 6

7.  Secondary:   Change in Distance Walked During 6-Minute Walk Test (6MWT)   [ Time Frame: 30 day, 1 year ]
  Show Outcome Measure 7

8.  Secondary:   Ratio of Days Alive Out of Hospital Versus Total Days Alive   [ Time Frame: 1 year ]
  Show Outcome Measure 8

9.  Secondary:   Quality of Life (QoL) Change   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 9

10.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 10

11.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 11

12.  Secondary:   Echocardiographic Assessment of Valve Performance   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 12

13.  Secondary:   Aortic Valve Hospitalizations   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 13

14.  Secondary:   Cardiovascular Deaths and Valve Related Deaths   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 14

15.  Secondary:   Strokes and Transient Ischemic Attacks (TIAs)   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 15

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

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

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

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

20.  Secondary:   Prosthetic Valve Dysfunction (PVD)   [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  Show Outcome Measure 20


  Serious Adverse Events
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  Other Adverse Events
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  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: Joleen Perkins
Organization: Medtronic, Inc.
e-mail: joleen.perkins@medtronic.com


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


Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01240902     History of Changes
Other Study ID Numbers: MCV-US-2009-01
Study First Received: November 10, 2010
Results First Received: March 6, 2015
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration