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Heart FailureNCT03155724

QP ExCELs: MultiPole Pacing (MPP) Sub-Study

A study testing MultiPole Pacing in people with Heart Failure, run by Biotronik, Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
MultiPole Pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
44 sitesUnited States
Study dates
19 May 2017to 23 Jan 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Northeast Cardiology

    Bangor, Maine, 04401

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UVM Medical

    Burlington, Vermont, 05401

  • UT Erlanger Cardiology

    Chattanooga, Tennessee, 37403

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • Southcoast Health

    Fall River, Massachusetts, 02720

  • Sanford Medical Center - Fargo

    Fargo, North Dakota, 58102

  • New York Presbyterian Queens

    Flushing, New York, 11355

  • Parkview Physicians Group - Cardiology

    Fort Wayne, Indiana, 46845

  • Fort Worth Heart

    Fort Worth, Texas, 76104

  • Upstate Cardiology

    Greenville, South Carolina, 29607

  • South Bay Electrophysiology

    Inglewood, California, 90301

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Glacier View Medical Research Institute, Cardiology

    Kalispell, Montana, 59901

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Baptist Health - Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Weill Cornell Medicine

    New York, New York, 10021

  • Mt. Sinai St. Luke's Hospital

    New York, New York, 10025

  • Florida Hospital

    Orlando, Florida, 32803

  • Orlando Health Heart Institute

    Orlando, Florida, 32806

  • Temple Heart and Vascular Institute

    Philadelphia, Pennsylvania, 19140

  • Eisenhower Desert Cardiology

    Rancho Mirage, California, 92270

  • SSM Health St. Joseph Hospital - St. Charles

    Saint Charles, Missouri, 63301

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Mercy Clinic Cardiology

    Springfield, Missouri, 65804

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Florida Hospital Tampa Pepin Heart Institute

    Tampa, Florida, 33613

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • UT Health Science Center

    The Woodlands, Texas, 77380

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

  • Westchester Medical Center

    Valhalla, New York, 10595

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Novant Health Winston-Salem Cardiology

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health Medical Center

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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
Being tested
MultiPole Pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MultiPole PacingDevice

    CRT non-responders are programmed with MultiPole pacing ON.

Study groups in NCT03155724
Study groupRoleWhat they receive
MultiPole PacingExperimentalTraditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Receives: Device: MultiPole Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Enrollment to 6 Months

Secondary outcomes (3)

  1. 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).

    Measured: Enrollment to 6 Months

  2. 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")

    Measured: Enrollment to 6 Months

  3. 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

    Measured: Enrollment to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start19 May 2017
  3. Primary completion23 Jan 2020
  4. Study completion23 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155724
Sponsor's protocol ID
MPP Sub-Study
Status last verified
Feb 2021
First submitted
15 May 2017
Last updated
8 Mar 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MultiPole Pacing in people with Heart Failure, run by Biotronik, Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature (time frame: Enrollment to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.

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QP ExCELs: MultiPole Pacing (MPP) Sub-Study | AzTrials