Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotronik, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Currently enrolled in the ongoing QP ExCELs study
Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or future-marketed CRT-D system with the MPP feature. Successful implantation is defined as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @ any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve stimulation at the final programmed pacing output at the time of enrollment into the MPP sub-study.
CRT Responder Assessment classification as "Worsened" or "Unchanged"
Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a Heart Failure (HF) hospitalization event)
Able to understand the nature of the sub-study and give informed consent
Available for an additional follow-up visit specific to the MPP sub-study at the investigational site
No evidence of non-compliance to their ongoing commitment in the QP ExCELs study
You may not be if
Have a life expectancy of less than 6 months
Expected to receive heart transplantation or ventricular assist device within 6 months
Chronic atrial fibrillation
Presence of another life-threatening, underlying illness separate from their cardiac disorder
Received MPP pacing prior to enrolment into the MPP sub-study
Clareo Health | QP ExCELs: MultiPole Pacing (MPP) Sub-Study
