Last updated on February 2020

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart failure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Standard CRT-D indication according to clinical routine
  • De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
  • Patient is able to understand the nature of the clinical investigation and provide written informed consent
  • Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
  • Patient accepts Home Monitoring concept
  • Age 18 years

Exclusion Criteria:

  • Contraindication to CRT-D therapy
  • Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
  • Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant (ablations planned to occur prior to or at implant are not exclusionary)
  • Expected to receive a heart transplant or ventricular assist device within 6 months
  • Life expectancy less than 12 months
  • Participation in any other investigational cardiac clinical investigation during the course of the study
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Pregnant or breast-feeding at time of enrollment

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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