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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Secondary ID [1] 0 0
MPP Sub-Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: MultiPole Pacing - Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Comparator / control treatment
Control group

Outcomes

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/01/2020
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT03155724
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03155724