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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   INGEVITY Active Fixation and Passive Fixation Pace/Sense Lead Clinical Study
Description   To gather data to establish the safety performance and effectiveness of the INGEVITY Active and Passive Fixation Pace/Sense Leads.
IRB Number   Pro4324
Inclusion/Notes   INCLUSION:
  • Subject is willing and capable of providing informed consent.

  • Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines.

  • Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol.

  • Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.

EXCLUSION:
  • Subject has or has had any pacing or ICD system implants.

  • Subject has a sensitivity to dexamethasone acetate (DXA).

  • Subject has a mechanical tricuspid heart valve.

  • Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries.

  • Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable).

  • Subject is currently on the active heart transplant list.

  • Subject has documented life expectancy of less than 12 months.

  • Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant.

  • Subjects currently requiring dialysis.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Dale Yoo MD
Contact Name   Alexa LeBlanc
Phone   (214) 361-3441

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