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

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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):
Medtronic Cardiovascular

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
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ATS 3f Aortic Bioprosthesis
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 26
Completed 1
Not Completed 25
Arm/Group Title ATS 3f Aortic Bioprosthesis
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
60.8  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
10
  38.5%
Male
16
  61.5%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Canada
17
  65.4%
United States
9
  34.6%
[1]
Measure Description: Recruiting sites included 4 in the US (n=9) and 1 in Canada (n=17)
1.Primary Outcome
Title 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
Hide Description Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.
Time Frame Six Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ATS 3f Aortic Bioprosthesis
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2.Secondary Outcome
Title Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
Hide Description Safety Analysis will be based on the the number of participants with cardiovascular complications.
Time Frame Six Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ATS 3f Aortic Bioprosthesis
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
11
Time Frame 6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ATS 3f Aortic Bioprosthesis
Hide Arm/Group Description

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

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

All-Cause Mortality
ATS 3f Aortic Bioprosthesis
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ATS 3f Aortic Bioprosthesis
Affected / at Risk (%) # Events
Total   8/26 (30.77%)    
Cardiac disorders   
Cardiovascular Complications  1  8/26 (30.77%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, Serious
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ATS 3f Aortic Bioprosthesis
Affected / at Risk (%) # Events
Total   3/26 (11.54%)    
Cardiac disorders   
Valve Dysfunction  1  3/26 (11.54%)  3
Vascular disorders   
Vascular Complication  1  2/26 (7.69%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, Serious
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
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