Heart Valve DiseasesPASNCT01116037
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
A study testing ATS 3f Aortic Bioprosthesis in people with Heart Valve Diseases, run by Medtronic Cardiovascular at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- ATS 3f Aortic Bioprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2009to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Baylor University
Dallas, Texas, 75226
Columbia University
New York, New York, 10032
Cardiac Surgery Clinical Research Center, Inc.
Oak Lawn, Illinois, 60453
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Main Line Health Heart Center
Wynnewood, Pennsylvania, 19096
About this study
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.
Read the 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.
- Conditions
- Heart Valve Diseases
- Being tested
- ATS 3f Aortic Bioprosthesis
- Keywords
- Diseased Heart Valve, Replacement, Aortic, Stentless
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATS 3f Aortic BioprosthesisDevice
Equine Pericardial Bioprosthesis for replacement of diseased valve
| Study group | Role | What they receive |
|---|---|---|
| ATS 3f Aortic Bioprosthesis | Other | ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) Receives: Device: ATS 3f Aortic Bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six Years
Secondary outcomes (1)
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.
Measured: Six Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Business decision to end study due to limited enrollment and study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116037
- Sponsor's protocol ID
- S2008 Rev. D
- Acronym
- PAS
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2010
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
- ClinicalTrials.gov ID
- NCT01116037
- Acronym / sponsor ID
- PAS / S2008 Rev. D
- Conditions
- Heart Valve Diseases
- Keywords
- Diseased Heart Valve, Replacement, Aortic, Stentless
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to end study due to limited enrollment and study population
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATS 3f Aortic Bioprosthesis | Other | Device: ATS 3f Aortic BioprosthesisATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATS 3f Aortic BioprosthesisEquine Pericardial Bioprosthesis for replacement of diseased valve | Device | ATS 3f Aortic Bioprosthesis |
Primary outcome
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
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.
1 secondary outcome
Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
Time frame: Six Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Medtronic Corporate WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Palmer study director
Medtronic
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATS 3f Aortic Bioprosthesis in people with Heart Valve Diseases, run by Medtronic Cardiovascular at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.