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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03155724
Registration number
NCT03155724
Ethics application status
Date submitted
15/05/2017
Date registered
16/05/2017
Date last updated
8/03/2021
Titles & IDs
Public title
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
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Scientific title
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
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Secondary ID [1]
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MPP Sub-Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MultiPole Pacing
Experimental: MultiPole Pacing - Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Treatment: Devices: MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
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Assessment method [1]
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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
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Timepoint [1]
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Enrollment to 6 Months
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Secondary outcome [1]
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Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
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Assessment method [1]
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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).
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Timepoint [1]
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Enrollment to 6 Months
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Secondary outcome [2]
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Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
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Assessment method [2]
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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")
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Timepoint [2]
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Enrollment to 6 Months
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Secondary outcome [3]
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CCS Responder Status Utilizing an Expanded Responder Classification
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Assessment method [3]
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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
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Timepoint [3]
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Enrollment to 6 Months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/01/2020
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Sample size
Target
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Accrual to date
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Final
53
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Vermont
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03155724
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03155724
Download to PDF