QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Heart Failure Clinical Trial

Official title:

QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155724
• Other study ID #: MPP Sub-Study
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: January 23, 2020

Study information

• Verified date: February 2021
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Northeast Cardiology	Bangor	Maine
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	UVM Medical	Burlington	Vermont
United States	UT Erlanger Cardiology	Chattanooga	Tennessee
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Thomas Hospital	Fairhope	Alabama
United States	Southcoast Health	Fall River	Massachusetts
United States	Sanford Medical Center - Fargo	Fargo	North Dakota
United States	New York Presbyterian Queens	Flushing	New York
United States	Parkview Physicians Group - Cardiology	Fort Wayne	Indiana
United States	Fort Worth Heart	Fort Worth	Texas
United States	Upstate Cardiology	Greenville	South Carolina
United States	South Bay Electrophysiology	Inglewood	California
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Glacier View Medical Research Institute, Cardiology	Kalispell	Montana
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	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Mt. Sinai St. Luke's Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Florida Hospital	Orlando	Florida
United States	Orlando Health Heart Institute	Orlando	Florida
United States	Temple Heart and Vascular Institute	Philadelphia	Pennsylvania
United States	Eisenhower Desert Cardiology	Rancho Mirage	California
United States	SSM Health St. Joseph Hospital - St. Charles	Saint Charles	Missouri
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Mercy Clinic Cardiology	Springfield	Missouri
United States	Florida Hospital Tampa Pepin Heart Institute	Tampa	Florida
United States	UT Health Science Center	The Woodlands	Texas
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Westchester Medical Center	Valhalla	New York
United States	MedStar Washington Hospital Center	Washington	District of Columbia
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	University of Massachusetts Medical School	Worcester	Massachusetts
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature	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	Enrollment to 6 Months
Secondary	Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 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).	Enrollment to 6 Months
Secondary	Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA	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")	Enrollment to 6 Months
Secondary	CCS Responder Status Utilizing an Expanded Responder Classification	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	Enrollment to 6 Months