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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MultiPole Pacing
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Hospital
  • South Bay Electrophysiology
  • Eisenhower Desert Cardiology
  • MedStar Washington Hospital Center
  • Florida Hospital
  • Orlando Health Heart Institute
  • Florida Hospital Tampa Pepin Heart Institute
  • Piedmont Heart Institute
  • University of Chicago Medical Center
  • Parkview Physicians Group - Cardiology
  • University of Iowa Hospitals and Clinics
  • University of Kansas Hospital
  • Baptist Health - Lexington
  • University of Kentucky
  • Northeast Cardiology
  • Massachusetts General Hospital
  • Southcoast Health
  • University of Massachusetts Medical School
  • University of Michigan Hospital
  • Henry Ford Hospital
  • Michigan Heart
  • Cardiology Associates of North Mississippi
  • SSM Health St. Joseph Hospital - St. Charles
  • St. Louis Heart and Vascular
  • Mercy Clinic Cardiology
  • Glacier View Medical Research Institute, Cardiology
  • Jersey Shore University Medical Center
  • Montefiore Medical Center
  • New York Presbyterian Queens
  • Weill Cornell Medicine
  • Mt. Sinai St. Luke's Hospital
  • Westchester Medical Center
  • Asheville Cardiology Associates
  • Novant Health Winston-Salem Cardiology
  • Wake Forest Baptist Health Medical Center
  • Sanford Medical Center - Fargo
  • University of Cincinnati
  • Temple Heart and Vascular Institute
  • Upstate Cardiology
  • UT Erlanger Cardiology
  • Fort Worth Heart
  • UT Health Science Center
  • University of Utah Medical Center
  • UVM Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MultiPole Pacing

Arm Description

Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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")
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

Full Information

First Posted
May 15, 2017
Last Updated
February 16, 2021
Sponsor
Biotronik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03155724
Brief Title
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Official Title
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MultiPole Pacing
Arm Type
Experimental
Arm Description
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Intervention Type
Device
Intervention Name(s)
MultiPole Pacing
Intervention Description
CRT non-responders are programmed with MultiPole pacing ON.
Primary Outcome Measure Information:
Title
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
Description
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
Time Frame
Enrollment to 6 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
Description
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).
Time Frame
Enrollment to 6 Months
Title
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
Description
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")
Time Frame
Enrollment to 6 Months
Title
CCS Responder Status Utilizing an Expanded Responder Classification
Description
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
Time Frame
Enrollment to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
South Bay Electrophysiology
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Eisenhower Desert Cardiology
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Health Heart Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Hospital Tampa Pepin Heart Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Parkview Physicians Group - Cardiology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baptist Health - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Northeast Cardiology
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Southcoast Health
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
SSM Health St. Joseph Hospital - St. Charles
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
St. Louis Heart and Vascular
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Mercy Clinic Cardiology
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Glacier View Medical Research Institute, Cardiology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mt. Sinai St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Novant Health Winston-Salem Cardiology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Baptist Health Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Medical Center - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Temple Heart and Vascular Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Upstate Cardiology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
UT Erlanger Cardiology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Fort Worth Heart
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
UT Health Science Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
UVM Medical
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

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