QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Study Overview
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Brief Summary
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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).

Official Title
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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MultiPole Pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MultiPole Pacing<br>Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. | Device: MultiPole Pacing<br>* CRT non-responders are programmed with MultiPole pacing ON.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature | 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 | Enrollment to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 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). | Enrollment to 6 Months | 
| Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA | 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) | Enrollment to 6 Months | 
| CCS Responder Status Utilizing an Expanded Responder Classification | 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 | Enrollment to 6 Months |