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Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)

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.
ClinicalTrials.gov Identifier: NCT01700439
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Intervention: Device: EDWARDS INTUITY valve

  Participant Flow

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
934 participants were considered enrolled; however, data are only available for 889 participants.

Reporting Groups
  Description
Edwards INTUITY Surgical Aortic Heart Valve Subjects who received an INTUITY study surgical aortic heart valve.

Participant Flow:   Overall Study
    Edwards INTUITY Surgical Aortic Heart Valve
STARTED   889 
Study Valve Group   839 [1] 
Discharge   831 
3 Month   778 
1 Year   573 
2 Year   215 
COMPLETED   0 
NOT COMPLETED   889 
[1] Received the Edwards INTUITY surgical aortic heart valve.



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Edwards INTUITY Surgical Aortic Heart Valve Subjects who received an Edwards INTUITY surgical aortic heart valve.

Baseline Measures
   Edwards INTUITY Surgical Aortic Heart Valve 
Overall Participants Analyzed 
[Units: Participants]
 839 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.5  (8.3) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      298  35.5% 
Male      541  64.5% 
[1] 839 are analyzed to date
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   0.4% 
Not Hispanic or Latino      773  92.1% 
Unknown or Not Reported      63   7.5% 
Region of Enrollment 
[Units: Participants]
 
United States   934 


  Outcome Measures

1.  Primary:   Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)   [ Time Frame: Events occurring ≥ 31 days and up through 2 years post-implant ]

2.  Secondary:   Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success   [ Time Frame: Day of procedure ]

3.  Secondary:   Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success   [ Time Frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first. ]

4.  Secondary:   Average Amount of Time Subject Spent on Cardiopulmonary Bypass   [ Time Frame: Day of procedure ]

5.  Secondary:   Average Subject Time on Cardiopulmonary Cross Clamp   [ Time Frame: Day of procedure ]

6.  Secondary:   Average Number of Days Subjects Were in the Intensive Care Unit (ICU)   [ Time Frame: Day of procedure through discharge from the hospital ]

7.  Secondary:   Subject’s Percentage of Change at 1 Year From Baseline in New York Heart Association (NYHA) Class   [ Time Frame: Baseline and one year follow-up ]

8.  Secondary:   Subject’s Average Gradient Measurements at 1 Year   [ Time Frame: 1 Year follow-up ]

9.  Secondary:   Subject’s Effective Orifice Area (EOA) Measurement at 1 Year   [ Time Frame: 1 Year follow-up ]

10.  Secondary:   Subject’s Effective Orifice Area Index (EOAI) Measurement at 1 Year   [ Time Frame: 1 year follow-up ]

11.  Secondary:   Subject’s Performance Index Measurement at 1 Year   [ Time Frame: 1 Year follow-up ]

12.  Secondary:   Subject’s Cardiac Output Measurement at 1 Year   [ Time Frame: 1 Year follow-up ]

13.  Secondary:   Subject’s Cardiac Index Measurement at 1 Year   [ Time Frame: 1 Year follow-up ]

14.  Secondary:   Amount of Aortic Valvular Regurgitation in Subjects at 1 Year by Valve Size   [ Time Frame: 1 Year follow-up ]

15.  Other Pre-specified:   Subject’s Average Score at Baseline and 1 Year on the Quality of Life Survey   [ Time Frame: Baseline and one year follow-up ]

16.  Other Pre-specified:   Subject’s Average White Blood Cell Count at 1 Year   [ Time Frame: 1 Year follow-up ]

17.  Other Pre-specified:   Subject’s Average Red Blood Cell Count at 1 Year   [ Time Frame: 1 Year follow-up ]

18.  Other Pre-specified:   Subject’s Average Hematocrit Percentage at 1 Year   [ Time Frame: 1 Year follow-up ]

19.  Other Pre-specified:   Subject’s Average Hemoglobin Percentage at 1 Year   [ Time Frame: 1 Year follow-up ]

20.  Other Pre-specified:   Subject’s Average Plasma Free Hemoglobin at 1 Year   [ Time Frame: 1 Year follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Mary Edwards, VP Clinical and Regulatory Affairs, HVT
Organization: Edwards Lifesciences, LLC
phone: 949-250-2500 ext 1536
e-mail: mary_edwards@edwards.com



Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01700439     History of Changes
Other Study ID Numbers: 2011-02
First Submitted: September 19, 2012
First Posted: October 4, 2012
Results First Submitted: September 22, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017