Interagency Registry of Mechanically Assisted Circulatory Support

Study ID
STU 032011-160

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jessica Crockett
214.456.4213
jessica.crockett@childrens.com

Principal Investigator
Kristine Guleserian

Summary

The scope of inTeRMaCS[RegisteredTM] encompasses those patients receiving MCSDs for whom discharge from the hospital is feasible. These devices are defined to be [Quote]durable[Quote] devices. This is a multi-site prospective data registry of clinical data, and/or tissue and blood specimens collected from patients receiving a MCSD to treat end-stage heart failure as either destination therapy, as bridge to transplant, or as bridge to recovery.

Patients will be asked to allow investigators/inTeRMaCS[RegisteredTM] to bank remnant intra-operative myocardial tissue and blood samples (taken at the time of MCSD implantation and explantation) at the nHLBi repository. if patients agree to have their tissue placed in the repository, they will also be asked if they would be willing to have Dna testing performed on their tissue sample(s). Patients will sign a separate consent form for this tissue repository. This tissue repository (and choice of genetic testing) is optional to the participant.

Dna Testing/Tissue Repository
The blood and myocardial tissue collection will take place during MCSD implantation surgery and explantation of the device; any inconvenience, danger, or discomfort may occur from the surgery and clinical processes, but not from the research derived from them. no more than 10 mLs (or 2 teaspoons) of blood will be taken at the time of device implantation or explantation. at the time of cardiac transplantation, segments from the explanted non-functioning heart will be harvested. Blood will be collected from a central venous line that will already be in place for surgery.

Data Collection Time Points
The medical char review and abstractions will be done: 1 week after implant, 1 month after implant, 3 months after implant, 6 months after implant and every six months thereafter while the device is in place

event driven data will be collected for death, device explantation, rehospitalization, and adverse events.

Questionnaire/neurocognitive Test
For patients that are 19 years of age or older, a quality of life questionnaire (euroQoL), and the Trail Making neurocognitive test will be administered pre-implantation when possible, at 3 months post-implantation and every 6 months post-implantation until the patient is bridged to transplantation, bridged to recovery or dies. The quality of life questionnaire and the Trail Making neurocognitive test require approximately 20 minutes to be completed.

Follow-up
all patients will be followed as long as the MCSD is in place. if a patient has a MCSD removed and is not transplanted, then the patient will be followed for 1 year for assessment of clinical status, survival and need for transplantation.

if a patient has an MCSD removed and is immediately transplanted, then the patient will no longer be followed in inTeRMaCS[RegisteredTM]. at that time, the patient will become part of the organ Procurement and Transplant network (oPTn) transplant database and will be followed in that database. any patient undergoing transplantation more than one year after device explantation will be included in inTeRMaCS for the first year, and then will re-enter follow-up through the oPTn at the time of transplantation.

if a patient transfers his/her care to: a non-inTeRMaCS[RegisteredTM] institution, then the patient will be censored at the time of transfer; pr another inTeRMaCS[RegisteredTM] institution, the patient will be asked to sign another consent form in order to continue participation in this study. if a patient revokes his/her consent, then the patient's data will be stopped at that point in time.

Participant Eligibility

Inclusion Criteria

All patients with a MCSD implanted on or after 3-1-2006 will be included whether it is their primary or subsequent device. The Registry will include every patient who receives an eligible MCSD.

Included Patients:

1) Patients who receive a durable mechanical circulatory support device (MCSD) which is FDA approved.

2) Patients who receive an MCSD after the hospital is activated (i.e., has received local IRB approval and has gained access to the INTERMACS(RegisteredTM) database). Patients who received an MCSD after March 1st, 2006 and before the hospital activation date are eligible for participation into INTERMACS(RegisteredTM), if the local IRB approves this inclusion criterion.