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THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial (PARTNER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530894
First Posted: September 18, 2007
Last Update Posted: September 13, 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):
Edwards Lifesciences
Results First Submitted: March 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Critical Aortic Stenosis
Interventions: Device: Edwards SAPIEN Transcatheter Heart Valve
Device: Surgical Valve Replacement
Other: medical management and/or balloon aortic valvuloplasty

  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
No text entered.

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
High Risk: TAVR Edwards SAPIEN Transcatheter Heart Valve
High Risk: SAVR Surgical Aortic Valve Replacement
Inoperable: TAVR Edwards SAPIEN Transcatheter Heart Valve
Inoperable: Medical Therapy Medical management and/or balloon aortic valvuloplasty

Participant Flow:   Overall Study
    High Risk: TAVR   High Risk: SAVR   Inoperable: TAVR   Inoperable: Medical Therapy
STARTED   348   351   179   179 
COMPLETED   260   236   124   85 
NOT COMPLETED   88   115   55   94 
Death                84                89                55                89 
Lost to Follow-up                1                3                0                0 
Withdrawal by Subject                1                23                0                5 
Alive and censored prior to 1 year                2                0                0                0 



  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.
The inoperable and high risk groups were not randomized against each other and were essentially two separate trials, therefore the pooled mean and standard deviations do not provide meaningful data and were not reported.

Reporting Groups
  Description
High Risk: TAVR Edwards SAPIEN Transcatheter Heart Valve
High Risk: SAVR Surgical Valve Replacement
Inoperable TAVR Edwards SAPIEN Transcatheter Heart Valve
Inoperable: Medical Therapy Medical management and/or balloon aortic valvuloplasty
Total Total of all reporting groups

Baseline Measures
   High Risk: TAVR   High Risk: SAVR   Inoperable TAVR   Inoperable: Medical Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 348   349   179   179   1055 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
         
High Risk   83.61  (6.83)   84.52  (6.37)   NA [1]   NA [1]   84.11  (6.61) 
Inoperable   NA [1]   NA [1]   83.12  (8.60)   83.18  (8.29)   83.18  (8.43) 
[1] The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      147  42.2%      151  43.3%      97  54.2%      95  53.1%      490  46.4% 
Male      201  57.8%      198  56.7%      82  45.8%      84  46.9%      565  53.6% 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   2   0   5   0   7 
Black/African American   11   8   4   9   32 
White   324   328   165   162   979 
Hispanic   9   9   5   8   31 
Other   2   4   0   0   6 
NYHA Class [1] [2] 
[Units: Participants]
         
High Risk Class II   20   21   NA [2]   NA [2]   41 
Operable Class II   NA [2]   NA [2]   14   11   25 
High Risk Class III or IV   328   328   NA [2]   NA [2]   656 
Inoperable Class III or IV   NA [2]   NA [2]   165   168   333 
[1] New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
[2] The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
Quality of Life [1] [2] 
[Units: Score]
Mean (Standard Deviation)
         
High Risk KCCQ Overall   39.6  (21.8)   44.5  (21.8)   NA [2]   NA [2]   41.88  (21.93) 
Inoperable KCCQ Overall   NA [2]   NA [2]   36.19  (20.52)   34.44  (20.14)   35.35  (20.32) 
High Risk SF-12 Physical   29.6  (7.6)   30.9  (8.2)   NA [2]   NA [2]   30.2  (7.9) 
Inoperable SF-12 Physical   NA [2]   NA [2]   28.23  (7.73)   27.70  (6.89)   28.0  (7.23) 
High Risk SF-12 Mental   46.9  (11.5)   47.6  (10.7)   NA [2]   NA [2]   47.2  (11.1) 
Inoperable SF-12 Mental   NA [2]   NA [2]   44.45  (12.16)   45.23  (11.03)   44.84  (11.5) 
[1] The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), EuroQOL, SF-12. The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
[2] The inoperable and high risk groups were not randomized against each other and were essentially two separate trials
STS Score [1] [2] 
[Units: Percentage]
Mean (Standard Deviation)
         
High Risk   11.8  (3.3)   11.7  (3.5)   NA [2]   NA [2]   11.75  (3.40) 
Inoperable   NA [2]   NA [2]   11.2  (5.8)   11.9  (4.8)   11.51  (5.34) 
[1] The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
[2] The inoperable and high risk groups were not randomized against each other and were essentially two separate trials


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Death   [ Time Frame: 1 Year ]

2.  Primary:   Composite of Death and Recurrence Hospitalization.   [ Time Frame: duration of study ]

3.  Secondary:   Functional Change of NYHA   [ Time Frame: Baseline to 1 year ]

4.  Secondary:   Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)   [ Time Frame: 1 year ]

5.  Secondary:   Total Hospital Days From the Index Procedure   [ Time Frame: 1 year ]

6.  Secondary:   Change in Quality of Life (QOL) From Baseline to 1 Year   [ Time Frame: Baseline and 1 Year ]


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Tenley Koepnick
Organization: Edwards Lifesciences
phone: 949-250-6504
e-mail: tenley_koepnick@edwards.com


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


Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00530894     History of Changes
Other Study ID Numbers: 2006-06-US
First Submitted: September 14, 2007
First Posted: September 18, 2007
Results First Submitted: March 7, 2016
Results First Posted: May 11, 2017
Last Update Posted: September 13, 2017



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