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ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study (PAS)

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: NCT01116037
Recruitment Status : Terminated (Business decision to end study due to limited enrollment and study population)
First Posted : May 4, 2010
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Heart Valve Diseases
Intervention: Device: ATS 3f Aortic Bioprosthesis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ATS 3f Aortic Bioprosthesis

ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)

ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve


Participant Flow:   Overall Study
    ATS 3f Aortic Bioprosthesis
STARTED   26 
COMPLETED   1 
NOT COMPLETED   25 



  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
ATS 3f Aortic Bioprosthesis

ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)

ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve


Baseline Measures
   ATS 3f Aortic Bioprosthesis 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  38.5% 
Male      16  61.5% 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
 
Canada   17 
United States   9 
[1] Recruiting sites included 4 in the US (n=9) and 1 in Canada (n=17)


  Outcome Measures

1.  Primary:   Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000   [ Time Frame: Six Years ]

2.  Secondary:   Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.   [ Time Frame: Six Years ]


  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Ryan Palmer
Organization: Medtronic
phone: +17635149732
e-mail: ryan.j.palmer@medtronic.com



Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01116037     History of Changes
Other Study ID Numbers: S2008 Rev. D
First Submitted: April 8, 2010
First Posted: May 4, 2010
Results First Submitted: October 17, 2016
Results First Posted: May 25, 2017
Last Update Posted: May 25, 2017