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).

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

53

Study ID:

NCT03155724

Recruitment Status:

Completed

Sponsor:

Biotronik, Inc.

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There are 44 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

53

Study ID:

NCT03155724

Recruitment Status:

Completed

Sponsor:


Biotronik, Inc.

How clear is this clinincal trial information?

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