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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Heart Failure
Title   Post Market Survey for CRT or CT-D (Heart / Heart Failure)
Description   The purpose of this study is to characterize the post market performance of the InSync defibrillator.
IRB Number   Pro112
Inclusion/Notes   INCLUSION:
  • Patients implanted with an InSync Model 8040, InSync III Model 8042 or any Medtronic market released CRT-D system, a transvenous RV lead, and a Medtronic market released LV lead, as part of a system to deliver CRT therapy.

  • Patients must provide written informed consent and agree to be accessible for follow- up at the study center.

EXCLUSION:
  • Patients with a history of a previously failed placement of an investigational Medtronic LV lead within 30 days of enrollment in the InSync Registry.
    (Rationale: To minimize the possibility of implant related events for patients participating in ongoing Medtronic investigational LV lead studies being attributed to the study’s goals).
Status   Completed
Location   Texas Health Harris Methodist Hospital Fort Worth
Principal Name    Kenneth Wade McBride MD
Contact Name   Tracie Bruton
Phone   (817) 820-4956

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