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Business decision to end study due to limited enrollment and study population
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The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\
A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATS 3f Aortic Bioprosthesis | Other | ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATS 3f Aortic Bioprosthesis | Device | Equine Pericardial Bioprosthesis for replacement of diseased valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Six Years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis Will be Based on the Occurence of Cardiovascular Complications. | Safety Analysis will be based on the the number of participants with cardiovascular complications. | Six Years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Palmer | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Surgery Clinical Research Center, Inc. | Oak Lawn | Illinois | 60453 | United States | ||
| Columbia University |
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| Label | URL |
|---|---|
| Medtronic Corporate Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Count of Participants | Participants | Six Years |
|
6 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular Complications | Cardiac disorders | Serious | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Valve Dysfunction | Cardiac disorders | Serious | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Palmer | Medtronic | +17635149732 | ryan.j.palmer@medtronic.com |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| New York |
| New York |
| 10032 |
| United States |
| Univ of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Main Line Health Heart Center | Wynnewood | Pennsylvania | 19096 | United States |
| Baylor University | Dallas | Texas | 75226 | United States |
| McGill University Health Center | Montreal | Quebec | H3A 1A1 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Recruiting sites included 4 in the US (n=9) and 1 in Canada (n=17) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Safety Analysis Will be Based on the Occurence of Cardiovascular Complications. | Safety Analysis will be based on the the number of participants with cardiovascular complications. | Posted | Number | participants | Six Years |
|
|
|
| 8 |
| 26 |
| 3 |
| 26 |
| Vascular Complication | Vascular disorders | Serious | Systematic Assessment |
|
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