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COMPASSION: COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00676689
First received: May 9, 2008
Last updated: July 21, 2016
Last verified: July 2016
Results First Received: May 4, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pulmonary Valve Insufficiency
Pulmonary Regurgitation
Dysfunctional RVOT Conduit
Pulmonary Obstruction
Pulmonary Stenosis
Intervention: Device: SAPIEN Transcatheter Valve Implantation

  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
SAPIEN THV No text entered.

Participant Flow:   Overall Study
    SAPIEN THV  
STARTED     81  
Procedure     79 [1]
30 Day Follow-up     78  
1 Year Follow-up     64  
COMPLETED     20  
NOT COMPLETED     61  
Screen Failure                 2  
Death                 2  
Lost to Follow-up                 4  
Physician Decision                 1  
Withdrawal by Subject                 3  
Continuing FU                 49  
[1] Two enrolled patients did not meet eligibility criteria and did not undergo the study procedure.



  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.
Safety Population (SP): All enrolled subjects for whom the procedure has begun, regardless of whether the valve was successfully implanted. The definition of “procedure has begun” is “the time of the creation of vascular access - incision or puncture.”

Reporting Groups
  Description
SAPIEN THV No text entered.

Baseline Measures
    SAPIEN THV  
Number of Participants  
[units: participants]
  79  
Age  
[units: years]
Mean (Standard Deviation)
  28.0  (13.97)  
Gender  
[units: participants]
 
Female     27  
Male     52  
New York Heart Association Group [1]
[units: participants]
 
Class I/II     54  
Class III/IV     25  
Primary Indication  
[units: participants]
 
Pulmonary Stenosis     7  
Pulmonary Regurgitation     10  
Both     62  
[1]

Class Patient Symptoms I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, shortness of breath.

II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath.

III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.




  Outcome Measures
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1.  Primary:   Freedom From Device or Procedure Related Death or Reintervention   [ Time Frame: 1 year ]

2.  Secondary:   Freedom From MACCE   [ Time Frame: 6 Months ]

3.  Secondary:   Functional Improvement   [ Time Frame: 6 months ]


  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 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: Donald Harkness
Organization: Edwards Lifesciences
phone: 949-250-3864
e-mail: donald_harkness@edwards.com



Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00676689     History of Changes
Other Study ID Numbers: 2006-09
Study First Received: May 9, 2008
Results First Received: May 4, 2016
Last Updated: July 21, 2016
Health Authority: United States: Food and Drug Administration