N/A
Completed N=53
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Source: ClinicalTrials.gov NCT03155724 ↗Enrolled (actual)
53
Serious AEs
9.4%
Results posted
Mar 2021
Primary outcomePrimary: Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature — 16; 23; 6 Participants — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature |
16; 23; 6 | <0.0001 sig |
| SECONDARY Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months. |
100 | — |
| SECONDARY Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA |
27; 11; 7 | — |
| SECONDARY CCS Responder Status Utilizing an Expanded Responder Classification |
39; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03155724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.