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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Sentus QP Related Complication-free Rate
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
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Sentus QP Time to Complication
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Sentus QP Related Complication-free Rate Per Lead Model
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Individual Sentus QP Adverse Event Rates
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
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
Sex
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
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/01/2020
Sample size
Target
Accrual to date
Final
2226
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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United States of America
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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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Montana
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New York
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North Carolina
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North Dakota
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Ohio
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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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Austria
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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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Germany
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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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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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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
State/province [70] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02290028