QP ExCELs: MultiPole Pacing (MPP) Sub-Study

• MultiPole Pacing (Device): CRT non-responders are programmed with MultiPole pacing ON.

Primary outcomes

• Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature [Enrollment to 6 Months]: Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) : * "Improved" * No HF hospitalization or cardiovascular death, AND * NYHA class is improved * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened

Secondary outcomes

• Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months. [Enrollment to 6 Months]: Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR).
• Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA [Enrollment to 6 Months]: Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse). Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit): * "Improved" * No HF hospitalization or cardiovascular death, AND * Neither NYHA class is worsened or PGA is worsened ("worse" or "markedly worse"), AND * NYHA class is improved or PGA is improved ("better" or "markedly better") * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged, AND * PGA is unchanged ("unchanged") * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened or PGA is worsened ("worse" or "markedly worse")
• CCS Responder Status Utilizing an Expanded Responder Classification [Enrollment to 6 Months]: Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) : * "Improved" * No HF hospitalization or cardiovascular death, AND * NYHA class is improved * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Participant flow

Outcome results

• Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature (Primary), Count of participants, Participants: MultiPole Pacing 16 (p <0.0001)
• Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months. (Secondary), Number, percentage of participants: MultiPole Pacing 100 (93.28 to 100.00)
• Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA (Secondary), Count of participants, Participants: MultiPole Pacing 27
• CCS Responder Status Utilizing an Expanded Responder Classification (Secondary), Count of participants, Participants: MultiPole Pacing 39

Adverse events

Time frame: 6 months

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2019-09-06)