Valvular Heart DiseaseEPICNCT00329667
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
A study testing EPIC in people with Valvular Heart Disease, run by Abbott Medical Devices.
Trial summary
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- EPIC
- Type of treatment
- Medical device
- How many people
- 761 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2008
- Phase
- Interventional
- 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
- The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
- The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
- The patient is of legal age in host country.
Who cannot join
- Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
- The patient requires replacement of the tricuspid or pulmonary valve.
- The patient is pregnant or nursing.
- Patient has active endocarditis.
- Patient is actively participating in the study of an investigational drug or device.
- Patient has had an acute preoperative neurological event.
Show all 10Show fewer
- The patient is undergoing renal dialysis.
- Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
- Patient has an inability or unwillingness to return for the required follow-up intervals.
- The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.
About this study
Official title: An Observational, Prospective Evaluation of the SJM Epic Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
Read the detailed description
This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:
- adverse effect rates
- clinical status as indicated by NYHA functional classification
- hemodynamic performance
- Conditions
- Valvular Heart Disease
- Being tested
- EPIC
- Keywords
- heart valve, mitral, aortic, valvular disease
- 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.
EPICDevice
Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effect rates
Measured: Ongoing
Clinical status as indicated by NYHA functional classification
Measured: At required follow-up visits
Hemodynamic performance
Measured: At required follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJan 2003
- Primary completionMar 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329667
- Sponsor's protocol ID
- CSD 0206
- Acronym
- EPIC
- Status last verified
- Feb 2019
- First submitted
- 23 May 2006
- Last updated
- 4 Feb 2019
- Results posted
- No
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
- An Observational, Prospective Evaluation of the SJM Epic Valve
- ClinicalTrials.gov ID
- NCT00329667
- Acronym / sponsor ID
- EPIC / CSD 0206
- Conditions
- Valvular Heart Disease
- Keywords
- heart valve, mitral, aortic, valvular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 May 2006 (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.
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
Detailed description
This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:
- adverse effect rates
- clinical status as indicated by NYHA functional classification
- hemodynamic performance
Study design
- Primary purpose
- Treatment
- 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)
- The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
- The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
- The patient is of legal age in host country.
Key exclusion criteria (10 listed)
- Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
- The patient requires replacement of the tricuspid or pulmonary valve.
- The patient is pregnant or nursing.
- Patient has active endocarditis.
- Patient is actively participating in the study of an investigational drug or device.
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 |
|---|---|---|
| EPICSurgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves | Device | – |
Primary outcome
Adverse effect rates
Time frame: Ongoing
Clinical status as indicated by NYHA functional classification
Time frame: At required follow-up visits
Hemodynamic performance
Time frame: At required follow-up visits
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EPIC in people with Valvular Heart Disease, run by Abbott Medical Devices.
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 10 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.
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 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?
Adverse effect rates (time frame: Ongoing). 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 4 Feb 2019.