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Completed

NCT Number: NCT03155724

QP ExCELs: MultiPole Pacing (MPP) Sub-Study

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Hospital, Fairhope, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MultiPole Pacing

Device

CRT non-responders are programmed with MultiPole pacing ON.

Primary outcomes

  1. 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

  1. Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.

    Time frame: 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).

  2. Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA

    Time frame: 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")

  3. CCS Responder Status Utilizing an Expanded Responder Classification

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Biotronik, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 16, 2017
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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