QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik, Inc.
- Enrollment
- 53
- Locations
- 44
- Primary Endpoint
- Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
Study Overview
Brief Summary
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Intervention: MultiPole Pacing (Device)
Outcomes
Primary Outcomes
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
Time Frame: 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)
- Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA(Enrollment to 6 Months)
- CCS Responder Status Utilizing an Expanded Responder Classification(Enrollment to 6 Months)