- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329667
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve (EPIC)
An Observational, Prospective Evaluation of the SJM Epic Valve
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse effect rates
Time Frame: Ongoing
|
Ongoing
|
Clinical status as indicated by NYHA functional classification
Time Frame: At required follow-up visits
|
At required follow-up visits
|
Hemodynamic performance
Time Frame: At required follow-up visits
|
At required follow-up visits
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSD 0206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Valvular Heart Disease
-
Dacima ConsultingTunisian Society of Cardiology and Cardiovascular SurgeryCompletedValvular Heart Disease | Valvular Stenosis | Valvular InsufficiencyTunisia
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
University of PennsylvaniaCompleted
-
Assiut UniversityCompleted
-
Assiut UniversityActive, not recruitingValvular Heart Disease Stenosis and RegurgitationEgypt
-
Cliniques universitaires Saint-Luc- Université...RecruitingValvular Heart Disease Stenosis and Regurgitation (Diagnosis)Belgium
-
Assiut UniversityRecruitingValvular Heart Disease Stenosis and RegurgitationEgypt
-
Ruijin HospitalMed-X Research Institute, Shanghai Jiao Tong UniversityRecruitingPrimary Valvular Heart Disease With Comorbid Coronary Artery Disease | Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart DiseaseChina
-
Cardenal Herrera UniversityUniversity of Valencia; Hospital de la RiberaNot yet recruitingExercise Based Prehabilitation in Valvular SurgerySpain
-
Yonsei UniversityCompletedValvular Heart Disease PatientsKorea, Republic of
Clinical Trials on EPIC
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
University of ManitobaCompletedOlder Adult Manual Wheelchair UsersCanada
-
Oxford Brookes UniversityUniversity of Oxford; National University of Ireland, MaynoothUnknownDevelopmental Coordination DisorderUnited Kingdom
-
Oxford Brookes UniversitySport England; Oxfordshire Sports PartnershipUnknown
-
Varian, a Siemens Healthineers CompanyCompleted
-
NYU Langone HealthCompletedCOVID | Corona Virus Infection | Adverse EventUnited States
-
Istituto Ortopedico RizzoliInternational Agency for Research on CancerRecruitingOsteosarcoma | Ewing SarcomaItaly