Heart Valve Diseases
Conditions
Keywords
Diseased Heart Valve, Replacement, Aortic, Stentless
Brief summary
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Detailed description
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.
Interventions
DEVICEATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient is \</= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue). * Patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups. * Patient is in satisfactory condition, based on the physical exam and Investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively). * Patient is geographically stable and willing to return to the implant center for follow-up visits. * Patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion criteria
* Patient is older than seventy (70) years of age. * Patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years. * Patient is an intravenous drug and/or alcohol abuser. * Female patient is pregnant (urine HCG test result positive), or lactating. * Patient presents with active endocarditis. * Patient presents with congenital bicuspid aortic anatomy. * This patient presents with abnormal aortic root geometry. * Patient has chronic renal failure or is on renal dialysis. * Patient has a previously implanted prosthetic valve that is not being replaced by a study valve. * Patient requires mitral, tricuspid or pulmonic valve replacement. * Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging. * Patient is participating in concomitant research studies of investigational products. * Patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Six Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Analysis Will be Based on the Occurence of Cardiovascular Complications. | Six Years | Safety Analysis will be based on the the number of participants with cardiovascular complications. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | ATS 3f Aortic Bioprosthesis |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment Canada | 17 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 26 |
| serious Total, serious adverse events | 8 / 26 |
Outcome results
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.
Time frame: Six Years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATS 3f Aortic Bioprosthesis | 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 | 1 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.
Time frame: Six Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATS 3f Aortic Bioprosthesis | Safety Analysis Will be Based on the Occurence of Cardiovascular Complications. | 11 participants |