04/12/2013 - The following administrative change regarding the Observational Study Monitoring Board’s (OSMB) annual meeting impacts the INTERMACS Protocol Version 3.0. A letter from INTERMACS (version date 4/12/2013) is attached to Protocol 3.0 and must accompany Protocol 3.0 from this day forward.

Protocol 3.0, Section, 1.0 - Executive Summary

Previous text, “The Data Coordinating Center has developed in consultation with the Operations Committee, (this committee consists of the INTERMACS co-PIs and representatives from the federal agencies and the data collection repository) an informed consent sample document and protocol to be used by each participating hospital in its preparation of materials for their IRB review and approval. All participating centers are required to obtain IRB approval before collecting registry data. Patients are required to be consented prior to case data being included in the registry. An NHLBI-appointed independent Observational Study Monitoring Board (OSMB) has been established to evaluate the registry on an ongoing basis as to procedures, findings, and adverse events to assure participant safety, confidentiality of records, and registry integrity. The OSMB advises the NHLBI and the INTERMACS® co-investigators when and if changes should be made. The OSMB meets twice a year”

Current text, “The Data Coordinating Center has developed in consultation with the Operations Committee, (this committee consists of the INTERMACS co-PIs and representatives from the federal agencies and the data collection repository) an informed consent sample document and protocol to be used by each participating hospital in its preparation of materials for their IRB review and approval. All participating centers are required to obtain IRB approval before collecting registry data. Patients are required to be consented prior to case data being included in the registry. An NHLBI-appointed independent Observational Study Monitoring Board (OSMB) has been established to evaluate the registry on an ongoing basis as to procedures, findings, and adverse events to assure participant safety, confidentiality of records, and registry integrity. The OSMB advises the NHLBI and the INTERMACS® co-investigators when and if changes should be made. The OSMB meets once a year”

Protocol 3.0, Section, 3.5 - Observational Study Monitoring Board (OSMB)

Previous Text, “An NHLBI-appointed independent Observational Study Monitoring Board (OSMB) has been established to evaluate the registry on an ongoing basis as to procedures, findings, and adverse events to assure participant safety, confidentiality of records, and registry integrity. The OSMB will advise the NHLBI and INTERMACS® co-investigators when and if changes should be made. The OSMB meets twice a year.”

Current Text, “An NHLBI-appointed independent Observational Study Monitoring Board (OSMB) has been established to evaluate the registry on an ongoing basis as to procedures, findings, and adverse events to assure participant safety, confidentiality of records, and registry integrity. The OSMB will advise the NHLBI and INTERMACS® co-investigators when and if changes should be made. The OSMB meets once a year.”

The above information will be incorporated into the next version of the protocol if amended.



09/18/2012 - The following administrative change regarding the Quality of Life measures impacts the INTERMACS Protocol Version 3.0. A letter from INTERMACS (version date 9/18/2012) is attached to Protocol 3.0 and must accompany Protocol 3.0 from this day forward.

Protocol 3.0, Section, 6.3 -Quality of Life Data

Previous text,
“Quality of Life (QOL) will be measured by the EuroQOL twenty three -item instrument. Pediatric patients (< 19 years of age) will not be asked to complete this instrument. We anticipate that completing these instruments will take the patient 20 minutes per instrument. Administering the instrument and entering the data into the registry will require approximately 30 minutes of coordinator time. The QOL instruments will be completed pre-implant (after consent) and post-implant (3 months, 6 months, and Q 6 months thereafter).”

Current text
, “Quality of Life (QOL) will be measured. We anticipate that completing these instruments will take the patient 20 minutes per instrument. Administering the instrument and entering the data into the registry will require approximately 30 minutes of coordinator time. The QOL instruments will be completed pre-implant (after consent) and post-implant (3 months, 6 months, and Q 6 months thereafter).”

The above information will be incorporated into the next version of the protocol if amended.

Protocol V3.0