Clinical trial NCT03155724: QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Official title: QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
timeFrame: Enrollment to 6 Months
Secondary outcomes:
measure: Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
timeFrame: Enrollment to 6 Months
measure: Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
timeFrame: Enrollment to 6 Months
measure: CCS Responder Status Utilizing an Expanded Responder Classification
timeFrame: Enrollment to 6 Months
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Inglewood
country: United States
facility: South Bay Electrophysiology
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Health Heart Institute
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Physicians Group - Cardiology
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Baptist Health - Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Bangor
country: United States
facility: Northeast Cardiology
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Southcoast Health
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Saint Charles
country: United States
facility: SSM Health St. Joseph Hospital - St. Charles
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cardiology
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Medical Research Institute, Cardiology
state: Montana
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: New York Presbyterian Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Mt. Sinai St. Luke's Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Winston-Salem Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center - Fargo
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Temple Heart and Vascular Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Chattanooga
country: United States
facility: UT Erlanger Cardiology
state: Tennessee
city: Fort Worth
country: United States
facility: Fort Worth Heart
state: Texas
city: The Woodlands
country: United States
facility: UT Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Burlington
country: United States
facility: UVM Medical
state: Vermont
Study officials:
References: