Heart Valve DiseasesNCT01156272
Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm
An observational study of Heart Valve Diseases, run by Medtronic Cardiovascular at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population 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 21 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were previously implanted with the ATS 3f Aortic Bioprosthesis Model 1000 (size 19mm) between the dates 1-Jan-2009 and 31-Dec-2009 and who meet the eligibility criteria.
Who may be able to join
- The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-2009. The three remaining heart valves must be of native tissue.
- The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
- The 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
- The patient is twenty (20) or less than twenty years of age.
- The patient is an intravenous drug and/or alcohol abuser.
- The patient presented for implant with active endocarditis.
- The patient presented for implant with congenital bicuspid aortic anatomy.
- The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
- The patient required mitral, tricuspid or pulmonic valve replacement.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
About this study
Official title: 3f 19mm IDE Study Rev D
The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Read the detailed description
A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA.
- Conditions
- Heart Valve Diseases
- Being tested
- ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm
- Keywords
- Isolated aortic valve replacement, heart valve
- 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 Medical 3f® Aortic Bioprosthesis, Model 1000 19mmDevice
Also called Model 1000, 19mm
Replacement aortic heart valve
| Study group | Role | What they receive |
|---|---|---|
| Replacement aortic heart valve | ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm Receives: Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
New York Heart Association (NYHA) Functional Classification
The NYHA classifications will be analyzed to demonstrate if implanting the of the study valve leads to an improvement in this clinical parameter for the patient.
Measured: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Blood Data
Blood data will be analyzed preoperative and postopertive to demonstrate if implanting of the study valve results in acceptable parameters for Serum Lactate Dehydrogenase (SLDH), Haptoglobin, Hematocrit and Reticulocyte parameters. Platelet and white blood cell count will also be analyzed.
Measured: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Adverse/complication rates
To demonstrate that the adverse/complication rates for the Model 1000 Bioprosthesis are less than two times the Objective Performance Criteria (OPCs) established by the FDA for severe complications.
Measured: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Study terminated prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Boulware, PhD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156272
- Sponsor's protocol ID
- 2009
- Status last verified
- Aug 2015
- First submitted
- 28 Jun 2010
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3f 19mm IDE Study Rev D
- ClinicalTrials.gov ID
- NCT01156272
- Acronym / sponsor ID
- 2009
- Conditions
- Heart Valve Diseases
- Keywords
- Isolated aortic valve replacement, heart valve
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated prematurely.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Detailed description
A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replacement aortic heart valve | – | Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mmATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were previously implanted with the ATS 3f Aortic Bioprosthesis Model 1000 (size 19mm) between the dates 1-Jan-2009 and 31-Dec-2009 and who meet the eligibility criteria.
Key inclusion criteria (3 listed)
- The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-2009. The three remaining heart valves must be of native tissue.
- The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
- The 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 (6 listed)
- The patient is twenty (20) or less than twenty years of age.
- The patient is an intravenous drug and/or alcohol abuser.
- The patient presented for implant with active endocarditis.
- The patient presented for implant with congenital bicuspid aortic anatomy.
- The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
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 Medical 3f® Aortic Bioprosthesis, Model 1000 19mmAlso: Model 1000, 19mmReplacement aortic heart valve | Device | Replacement aortic heart valve |
Primary outcome
New York Heart Association (NYHA) Functional Classification
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
The NYHA classifications will be analyzed to demonstrate if implanting the of the study valve leads to an improvement in this clinical parameter for the patient.
Blood Data
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Blood data will be analyzed preoperative and postopertive to demonstrate if implanting of the study valve results in acceptable parameters for Serum Lactate Dehydrogenase (SLDH), Haptoglobin, Hematocrit and Reticulocyte parameters. Platelet and white blood cell count will also be analyzed.
Adverse/complication rates
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
To demonstrate that the adverse/complication rates for the Model 1000 Bioprosthesis are less than two times the Objective Performance Criteria (OPCs) established by the FDA for severe complications.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Corporate WebsiteLink provided by the sponsor.
Related trials for Heart Valve Diseases
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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.
Mike Boulware, PhD study director
Medtronic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by Medtronic Cardiovascular at 1 site in Canada.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
New York Heart Association (NYHA) Functional Classification (time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months). The study lists 3 primary outcomes in all. 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 6 Aug 2015.