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.

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.

City, postcode or hospital

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

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 group	Role	What they receive
MultiPole Pacing	Experimental	Traditional 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.

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)

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
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
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.

19 May 201723 Jan 2020

First posted16 May 2017
Study start19 May 2017
Primary completion23 Jan 2020
Study completion23 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
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Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QP ExCELs: MultiPole Pacing (MPP) Sub-Study
ClinicalTrials.gov ID: NCT03155724
Acronym / sponsor ID: MPP Sub-Study
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: 19 May 2017 (actual)
Primary completion: 23 Jan 2020 (actual)
Study completion: 23 Jan 2020 (actual)
First posted: 16 May 2017 (actual)
Results: Posted 8 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MultiPole Pacing	Experimental	Device: MultiPole PacingTraditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MultiPole PacingCRT non-responders are programmed with MultiPole pacing ON.	Device	MultiPole Pacing

Primary outcome

Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
Time frame: Enrollment to 6 Months
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

3 secondary outcomes

Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
Time frame: Enrollment to 6 Months
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
Time frame: Enrollment to 6 Months
CCS Responder Status Utilizing an Expanded Responder Classification
Time frame: Enrollment to 6 Months

Results and safety

Results posted to the registry on 8 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MultiPole Pacing	53	42

Primary outcome: Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature

Time frame: Enrollment to 6 Months. Count of participants. Unit: Participants

Measure	MultiPole Pacing n = 45
Improved	16
Unchanged	23
Worsened	6

MultiPole Pacing: p <0.0001, Exact, binomial, one-sided

Population analysed: Participants who have completed the MultiPole Pacing (MPP) Sub-study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MultiPole Pacing	5 of 53 (9.4%)	6 of 53 (11.3%)	3 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure

RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
CCM OPEN HF Registry
Heart Failure
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

44 sites in 1 country: see every site and its status.

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; AzTrials last refreshed its copy on 28 Oct 2026.