QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Not Applicable

Completed

Conditions: Heart Failure

Registration Number: NCT03155724

Lead Sponsor: Biotronik, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (44): Thomas Hospital
🇺🇸
Fairhope, Alabama, United States
South Bay Electrophysiology
🇺🇸
Inglewood, California, United States
Eisenhower Desert Cardiology
🇺🇸
Rancho Mirage, California, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Orlando Health Heart Institute
🇺🇸
Orlando, Florida, United States
Florida Hospital Tampa Pepin Heart Institute
🇺🇸
Tampa, Florida, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Parkview Physicians Group - Cardiology
🇺🇸
Fort Wayne, Indiana, United States
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Thomas Hospital
🇺🇸Fairhope, Alabama, United States