Aortic Valve StenosisPhase 4NCT00256165
REST Study: Left Ventricular Regression European Study
A Phase 4 study testing Tissue valve in people with Aortic Valve Stenosis, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with echocardiography (2-dimensional [2D]… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Tissue valve
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires, for the first time, isolated aortic valve replacement due to aortic stenosis or mixed aortic stenosis disease etiology when aortic stenosis is predominant and aortic regurgitation is mild.
- Patient is of legal age in the host country.
- Patient (or legal guardian) has signed a study specific informed consent form
Who cannot join
- Patient was previously operated on with any heart surgery including heart valve replacement or coronary artery bypass graft (CABG); or underwent any form of myocardial revascularization in the past (including stents), etc.
- Patient requires any concomitant heart surgery other than the isolated native aortic heart valve replacement and concomitant ascending aortic replacement (e.g not allowed are: multiple valve replacements or concomitant CABG, pacemaker insertions, or severe septal hypertrophy needing surgical excision, etc.)
- Patient has unstable angina
- Patient is in New York Heart Association functional class IV
- Patient has significant abnormality in wall motion
- Patient is affected by active endocarditis.
Show all 19Show fewer
- Patient has a cardiac pacemaker or automatic implanted cardiac defibrillator
- Patient is affected by acute aortic dissection.
- Patient is in chronic and persistent atrial fibrillation
- Patient receives hemodialysis therapy
- Patient has a medical condition which contraindicates implantation of the SJM Epic and Epic™ Supra Porcine Bioprosthetic Heart Valve (e.g. renal failure or abnormal calcium metabolism).
- Patient has aneurysmal clips or carotid artery vascular stents
- Patient has a neurostimulator
- Patient has an implanted or external drug infusion device (e.g. insulin pump)
- Patient has a bone growth/fusion stimulator
- Patient has a cochlear, otologic, or ear implant
- Patients with severe claustrophobia in which medical sedation is contraindicated or unable to resolve anxiety sufficiently
- Patients with ocular foreign body (e.g. metal shavings)
- Patient is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the technology is available).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Tissue valve
- Keywords
- Aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue valveDevice
Aortic valve replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- G. Gerosa, Prof., Principal investigator, Policlinico Universitario Cardiovasculare - Padua - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256165
- Sponsor's protocol ID
- CS04009TV
- Status last verified
- Feb 2019
- First submitted
- 16 Nov 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Breitenbach I, Harringer W, Tsui S, Amorim MJ, Herregods MC, Bogaert J, Goiti JJ, Gerosa G. Magnetic resonance imaging versus echocardiography to ascertain the regression of left ventricular hypertrophy after bioprosthetic aortic valve replacement: results of the REST study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):640-645.e1. doi: 10.1016/j.jtcvs.2011.11.017. Epub 2011 Dec 10.
PubMed 22154789
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Regression European Study
- ClinicalTrials.gov ID
- NCT00256165
- Acronym / sponsor ID
- CS04009TV
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 Nov 2005 (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 obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the technology is available).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient requires, for the first time, isolated aortic valve replacement due to aortic stenosis or mixed aortic stenosis disease etiology when aortic stenosis is predominant and aortic regurgitation is mild.
- Patient is of legal age in the host country.
- Patient (or legal guardian) has signed a study specific informed consent form
Key exclusion criteria (19 listed)
- Patient was previously operated on with any heart surgery including heart valve replacement or coronary artery bypass graft (CABG); or underwent any form of myocardial revascularization in the past (including stents), etc.
- Patient requires any concomitant heart surgery other than the isolated native aortic heart valve replacement and concomitant ascending aortic replacement (e.g not allowed are: multiple valve replacements or concomitant CABG, pacemaker insertions, or severe septal hypertrophy needing surgical excision, etc.)
- Patient has unstable angina
- Patient is in New York Heart Association functional class IV
- Patient has significant abnormality in wall motion
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 |
|---|---|---|
| Tissue valveAortic valve replacement | Device | – |
Primary outcome
The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 22154789Breitenbach I, Harringer W, Tsui S, Amorim MJ, Herregods MC, Bogaert J, Goiti JJ, Gerosa G. Magnetic resonance imaging versus echocardiography to ascertain the regression of left ventricular hypertrophy after bioprosthetic aortic valve replacement: results of the REST study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):640-645.e1. doi: 10.1016/j.jtcvs.2011.11.017. Epub 2011 Dec 10.
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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.
G. Gerosa, Prof. principal investigator
Policlinico Universitario Cardiovasculare - Padua - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tissue valve in people with Aortic Valve Stenosis, run by Abbott Medical Devices at 1 site in Germany.
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 19 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: finished, as of the sponsor's last update on 4 Feb 2019. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256165, which also lists 1 linked publication.
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 4 Feb 2019.