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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02290028




Registration number
NCT02290028
Ethics application status
Date submitted
10/11/2014
Date registered
13/11/2014
Date last updated
24/03/2021

Titles & IDs
Public title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Scientific title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Secondary ID [1] 0 0
CR016
Universal Trial Number (UTN)
Trial acronym
QP ExCELs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sentus QP left ventricular lead

Other: Sentus QP left ventricular lead - Subjects consented and implanted with a Sentus QP left ventricular lead.


Treatment: Devices: Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sentus QP Related Complication-free Rate Through 6 Months - The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months - The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Sentus QP Related Complication-free Rate - The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model - The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months - The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model - The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model - The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Sentus QP Time to Complication - The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Sentus QP Related Complication-free Rate Per Lead Model - The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Individual Sentus QP Adverse Event Rates - The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold - The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.
Timepoint [8] 0 0
12 months

Eligibility
Key inclusion criteria
- Standard CRT-D indication according to clinical routine

- De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a
BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead

- Patient is able to understand the nature of the clinical investigation and provide
written informed consent

- Patient is able and willing to complete all routine study visits at the
investigational site through 5 years of follow-up

- Patient accepts Home Monitoring® concept

- Age = 18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chronic atrial fibrillation

- Contraindication to CRT-D therapy

- Currently implanted with an endocardial or epicardial left ventricular lead or had
prior attempt to place a left ventricular lead

- Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that
is planned to occur within 6 months after implant or ablation that is planned to occur
within 90 days after implant (ablations planned to occur prior to or at implant are
not exclusionary)

- Expected to receive a heart transplant or ventricular assist device within 6 months

- Life expectancy less than 12 months

- Participation in any other investigational cardiac clinical investigation during the
course of the study

- Presence of another life-threatening, underlying illness separate from their cardiac
disorder

- Pregnant or breast-feeding at time of enrollment

Study design
Purpose of the study
Other
Allocation to intervention
N/A
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [2] 0 0
Lyell McEwing Hospital - Elizabeth Vale
Recruitment hospital [3] 0 0
The Northern Hospital - Epping
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment postcode(s) [3] 0 0
- Epping
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
- Nambour
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New York
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Vermont
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Wisconsin
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Wyoming
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Austria
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Linz
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Wels
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Austria
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Wien
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Denmark
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Hellerup
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Denmark
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Odense
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Germany
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Berlin
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Bernau
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Bielefeld
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Bochum
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Düsseldorf
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Erlangen
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Essen
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Freiburg
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Gera
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Kaiserslautern
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Leipzig
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Lübeck
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Lünen
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Stade
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Villingen
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Würzburg
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Zwickau
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Hungary
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Budapest
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Italy
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Brescia
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Italy
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Como
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Spain
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Barcelona
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Madrid
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Switzerland
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Luzern
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Switzerland
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Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik SE & Co. KG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biotronik, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP
left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in
the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.

Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed
during the ongoing post approval phase (US sites only).

A protocol update was implemented on September 6, 2019 to transition the long-term follow up
for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
Trial website
https://clinicaltrials.gov/show/NCT02290028
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antonio Curnis, Prof.
Address 0 0
Spedali Civili - Universita di Brescia, Italy
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/show/NCT02290028