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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   Siello Clinical Study (Cardiology)
Description   The purpose of this study is to confirm safety and reliability of the BIOTRONIK Siello lead as used in conjunction with any BIOTRONIK Evia pacemaker device.
IRB Number   Pro4741
Inclusion/Notes   INCLUSION:
  • Candidate for de novo implantation of a BIOTRONIK Evia pacemaker system, including one or two Siello leads.

  • Candidate meets recommendation for pacemaker system implant put forth by guidelines of relevant professional societies.

  • Able to understand the nature of the study and provide informed consent.

  • Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up.

  • Age greater than or equal to 18 years.

EXCLUSION:
  • Enrolled in any other investigational clinical study.

  • Currently implanted with a pacemaker or ICD device.

  • Planned cardiac surgical procedures or interventional measures within the next 6 months.

  • Expected to receive a heart transplant within 1 year.

  • Life expectancy less than 1 year.

  • Presence of another life-threatening, underlying illness separate from their cardiac disorder.

  • Pregnant at the time of enrollment.
Status   Recruiting
Location   Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Principal Name    Tu Khac Phan Le MD
Contact Name   Jeanette Hatfield
Phone   (817) 545-4550

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