QP ExCELs: MultiPole Pacing (MPP) Sub-Study

NCT03155724 | Completed Results DMC FDA Device

• 1 other identifier: MPP Sub-Study
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 44

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.

  Enrollment to 6 Months

• Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA

  Enrollment to 6 Months

• CCS Responder Status Utilizing an Expanded Responder Classification

  Enrollment to 6 Months

Study Arms (1)

MultiPole Pacing

EXPERIMENTAL

Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.

Device: MultiPole Pacing

Interventions

MultiPole Pacing DEVICE

CRT non-responders are programmed with MultiPole pacing ON.

MultiPole Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (44)

Thomas Hospital

Fairhope, Alabama, 36532, United States

Location

South Bay Electrophysiology

Inglewood, California, 90301, United States

Location

Eisenhower Desert Cardiology

Rancho Mirage, California, 92270, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Orlando Health Heart Institute

Orlando, Florida, 32806, United States

Location

Florida Hospital Tampa Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Parkview Physicians Group - Cardiology

Fort Wayne, Indiana, 46845, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health - Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Northeast Cardiology

Bangor, Maine, 04401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Southcoast Health

Fall River, Massachusetts, 02720, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

SSM Health St. Joseph Hospital - St. Charles

Saint Charles, Missouri, 63301, United States

Location

Mercy Clinic Cardiology

Springfield, Missouri, 65804, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Glacier View Medical Research Institute, Cardiology

Kalispell, Montana, 59901, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

New York Presbyterian Queens

Flushing, New York, 11355, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Mt. Sinai St. Luke's Hospital

New York, New York, 10025, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

Novant Health Winston-Salem Cardiology

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Health Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Temple Heart and Vascular Institute

Philadelphia, Pennsylvania, 19140, United States

Location

Upstate Cardiology

Greenville, South Carolina, 29607, United States

Location

UT Erlanger Cardiology

Chattanooga, Tennessee, 37403, United States

Location

Fort Worth Heart

Fort Worth, Texas, 76104, United States

Location

UT Health Science Center

The Woodlands, Texas, 77380, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

UVM Medical

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Studies Engineer Manager
• Organization: BIOTRONIK

crystal.miller@biotronik.com

800-547-0394

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: May 19, 2017
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-02

Locations

US (44)