QP ExCELs: MultiPole Pacing (MPP) Sub-Study
- Conditions
- Heart Failure
- Interventions
- Device: MultiPole Pacing
- 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
- 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
- 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
- Arm && Interventions
Group Intervention Description MultiPole Pacing MultiPole Pacing Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
- 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
Related Research Topics
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Trial Locations
- Locations (44)
Thomas Hospital
🇺🇸Fairhope, Alabama, United States
Parkview Physicians Group - Cardiology
🇺🇸Fort Wayne, Indiana, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Glacier View Medical Research Institute, Cardiology
🇺🇸Kalispell, Montana, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
UT Erlanger Cardiology
🇺🇸Chattanooga, Tennessee, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Southcoast Health
🇺🇸Fall River, Massachusetts, United States
Eisenhower Desert Cardiology
🇺🇸Rancho Mirage, California, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Baptist Health - Lexington
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
SSM Health St. Joseph Hospital - St. Charles
🇺🇸Saint Charles, Missouri, United States
St. Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cardiology
🇺🇸Springfield, Missouri, United States
New York Presbyterian Queens
🇺🇸Flushing, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Mt. Sinai St. Luke's Hospital
🇺🇸New York, New York, United States
Temple Heart and Vascular Institute
🇺🇸Philadelphia, Pennsylvania, United States
Upstate Cardiology
🇺🇸Greenville, South Carolina, United States
Fort Worth Heart
🇺🇸Fort Worth, Texas, United States
UT Health Science Center
🇺🇸The Woodlands, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Sanford Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Northeast Cardiology
🇺🇸Bangor, Maine, United States
Cardiology Associates of North Mississippi
🇺🇸Tupelo, Mississippi, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
UVM Medical
🇺🇸Burlington, Vermont, United States
Florida Hospital Tampa Pepin Heart Institute
🇺🇸Tampa, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Orlando Health Heart Institute
🇺🇸Orlando, Florida, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Novant Health Winston-Salem Cardiology
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest Baptist Health Medical Center
🇺🇸Winston-Salem, North Carolina, United States
South Bay Electrophysiology
🇺🇸Inglewood, California, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States