- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669357
AbioCor Implantable Replacement Heart
May 1, 2013 updated by: Abiomed Inc.
Abiocor is a post market approval study for an Implantable Replacement Heart.
This post approval study is currently on hold.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.
Exclusion Criteria:
- Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 25, 2008
First Submitted That Met QC Criteria
April 29, 2008
First Posted (Estimate)
April 30, 2008
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H040006
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 Severe Biventricular End Stage Heart Disease
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Berlin Heart, IncUnknownSevere Isolated Left Ventricular Dysfunction | Severe Biventricular Dysfunction
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Imperial College LondonNational Institute for Health Research, United Kingdom; Imperial College Healthcare...WithdrawnMyocardial Fibrosis | Heart Failure | End Stage Renal Failure on Dialysis | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe)United Kingdom
-
University of VermontMedical University of South Carolina; University of Washington; University of...Active, not recruitingEnd Stage Renal Disease | Severe Life-limiting COPD | Severe Life-limiting Heart Failure | Severe Life-limiting Cirrhosis | Severe Life-limiting Malignancy | Severe Functional ImpairmentUnited States
-
Hospices Civils de LyonCompletedEnd Stage DiseaseFrance
-
Food and Health Bureau, Hong KongUnited Christian Hospital; Haven of Hope HospitalCompletedEnd Stage DiseaseHong Kong
-
The Hong Kong Polytechnic UniversityCompletedHeart Failure | End Stage Heart DiseaseHong Kong
-
Patient Care AmericaBaxter Healthcare CorporationActive, not recruitingEnd-stage Renal Disease | Malnutrition; ProteinUnited States
-
Nanyang Technological UniversityNational Kidney Foundation, SingaporeRecruitingEnd Stage Renal Disease | End Stage Kidney Disease | End Stage Renal Failure on Dialysis | End Stage Renal Disease on DialysisSingapore
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA); The Greenwall Foundation; Emily Davie and...CompletedHeart Failure | End-stage DiseaseUnited States
-
RenJi HospitalNot yet recruitingEnd Stage Liver DIsease
Clinical Trials on Abiocor Implantable Replacement Heart
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Stichting Epilepsie Instellingen NederlandMedtronic; Fonds NutsOhraCompletedEpilepsy | Asystole | Cardiac ArrhythmiasNetherlands
-
Nuwellis, Inc.Terminated
-
On-X Life Technologies, Inc.CompletedHeart Valve DiseaseUnited States, Canada, Netherlands, India, Australia, Germany, Norway, South Africa, Sweden
-
Nuwellis, Inc.Completed
-
Venus MedTech (HangZhou) Inc.IQVIA Inc.; TheraGenesis; IntrialsActive, not recruiting
-
Medtronic Cardiac SurgeryRecruitingValve Disease, HeartUnited States, Belgium, Greece, Germany, Netherlands, Austria, France, Italy, Switzerland, Spain
-
Nanjing Medical UniversityCompletedCheyne-Stokes Respiration | Heart Valve Disease | Central Sleep ApneaChina
-
Abbott Medical DevicesCompletedAortic Valve Stenosis | Mitral Valve Insufficiency | Aortic Valve Insufficiency | Mitral Valve Stenosis | Mitral Valve Regurgitation | Aortic Valve Incompetence | Mitral Valve Incompetence | Aortic Valve RegurgitationUnited States
-
Corcym S.r.lCompleted
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Corcym S.r.lActive, not recruitingAortic Valve Stenosis | Aortic Valve DiseaseChina