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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: MultiPole Pacing

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
  • California
    • Inglewood, California, United States, 90301
      • South Bay Electrophysiology
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Cardiology
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Orlando, Florida, United States, 32806
      • Orlando Health Heart Institute
    • Tampa, Florida, United States, 33613
      • Florida Hospital Tampa Pepin Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Physicians Group - Cardiology
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health - Lexington
  • Maine
    • Bangor, Maine, United States, 04401
      • Northeast Cardiology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Fall River, Massachusetts, United States, 02720
      • Southcoast Health
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of North Mississippi
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • SSM Health St. Joseph Hospital - St. Charles
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Cardiology
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Medical Research Institute, Cardiology
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Flushing, New York, United States, 11355
      • New York Presbyterian Queens
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
    • New York, New York, United States, 10025
      • Mt. Sinai St. Luke's Hospital
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Winston-Salem Cardiology
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Medical Center - Fargo
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Heart and Vascular Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Upstate Cardiology
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • UT Erlanger Cardiology
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Fort Worth Heart
    • The Woodlands, Texas, United States, 77380
      • UT Health Science Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • UVM Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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, ANDNYHA class is improved; "Unchanged"No HF hospitalization or cardiovascular death, ANDNYHA class is unchanged; "Worsened"HF hospitalization or cardiovascular death has occurred, ORNYHA 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, ANDNeither NYHA class is worsened or PGA is worsened ("worse" or "markedly worse"), ANDNYHA class is improved or PGA is improved ("better" or "markedly better"); "Unchanged"No HF hospitalization or cardiovascular death, ANDNYHA class is unchanged, ANDPGA is unchanged ("unchanged"); "Worsened"HF hospitalization or cardiovascular death has occurred, ORNYHA 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, ANDNYHA class is improved; "Unchanged"No HF hospitalization or cardiovascular death, ANDNYHA class is unchanged; "Worsened"HF hospitalization or cardiovascular death has occurred, ORNYHA class is worsened	Enrollment to 6 Months

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MPP Sub-Study

Drug and device information, study documents

• 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