QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT03155724

Run by

Biotronik, Inc.

People needed

53

Starts

2017-05-19

Expected to finish

2020-01-23

Last updated by the study team

2021-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Hospital — Fairhope, Alabama, United States
• South Bay Electrophysiology — Inglewood, California, United States
• Eisenhower Desert Cardiology — Rancho Mirage, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Florida Hospital — Orlando, Florida, United States
• Orlando Health Heart Institute — Orlando, Florida, United States
• Florida Hospital Tampa Pepin Heart Institute — Tampa, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Parkview Physicians Group - Cardiology — Fort Wayne, Indiana, 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
• Northeast Cardiology — Bangor, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Southcoast Health — Fall River, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• SSM Health St. Joseph Hospital - St. Charles — Saint Charles, Missouri, United States
• Mercy Clinic Cardiology — Springfield, Missouri, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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