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Trial record 1 of 1 for:    NCT03155724
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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

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ClinicalTrials.gov Identifier: NCT03155724
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: MultiPole Pacing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Actual Study Start Date : May 19, 2017
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Arm Intervention/treatment
Experimental: MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Device: MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.




Primary Outcome Measures :
  1. Evaluate CRT responder status with the MPP feature within the Ilivia HF-T QP family CRT-D or future-marketed CRT-D system. [ Time Frame: Enrollment to 6 Months ]

    Proportion of subjects who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in NYHA class, 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 :
  1. Freedom from 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 of the Ilivia HF-T QP family, or future-marketed CRT-D system with 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.

  2. Evaluate 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 subjects to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse).

  3. Evaluate CCS Responder Status utilizing a modified Responder Classification [ Time Frame: Enrollment to 6 Months ]
    Evaluate a modified Responder Classification in which both "Improved" and "Unchanged" subjects will be classified as responders.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155724


Locations
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Sponsors and Collaborators
Biotronik, Inc.

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Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT03155724    
Other Study ID Numbers: MPP Sub-Study
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases