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Sentus QP-Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)
Pre Market: Confirm the safety and effectiveness of the BIOTRONIK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 6 months post-implant. The evaluation of effectiveness will be based on LV pacing capture thresholds.
Post-Approval: confirm long-term safety of the BIOTRONICK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
Pre Market: Confirm the safety and effectiveness of the BIOTRONIK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 6 months post-implant. The evaluation of effectiveness will be based on LV pacing capture thresholds.
Post-Approval: confirm long-term safety of the BIOTRONICK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
Recruitment Status
Past Studies