Heart Failure Clinical Trial
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
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).
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
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There are 44 Locations for this study
Fairhope Alabama, 36532, United States
Inglewood California, 90301, United States
Rancho Mirage California, 92270, United States
Washington District of Columbia, 20010, United States
Orlando Florida, 32803, United States
Orlando Florida, 32806, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30309, United States
Chicago Illinois, 60637, United States
Fort Wayne Indiana, 46845, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40536, United States
Bangor Maine, 04401, United States
Boston Massachusetts, 02114, United States
Fall River Massachusetts, 02720, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Ypsilanti Michigan, 48197, United States
Tupelo Mississippi, 38801, United States
Saint Charles Missouri, 63301, United States
Saint Louis Missouri, 63136, United States
Springfield Missouri, 65804, United States
Kalispell Montana, 59901, United States
Neptune New Jersey, 07753, United States
Bronx New York, 10467, United States
Flushing New York, 11355, United States
New York New York, 10021, United States
New York New York, 10025, United States
Valhalla New York, 10595, United States
Asheville North Carolina, 28803, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58102, United States
Cincinnati Ohio, 45219, United States
Philadelphia Pennsylvania, 19140, United States
Greenville South Carolina, 29607, United States
Chattanooga Tennessee, 37403, United States
Fort Worth Texas, 76104, United States
The Woodlands Texas, 77380, United States
Salt Lake City Utah, 84132, United States
Burlington Vermont, 05401, United States
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