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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02774616




Registration number
NCT02774616
Ethics application status
Date submitted
13/05/2016
Date registered
17/05/2016

Titles & IDs
Public title
BIO|MASTER.Ilivia Family / Plexa
Scientific title
BIO|MASTER.Ilivia Family / Plexa
Secondary ID [1] 0 0
TA111
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Ilivia ICD Family
Treatment: Devices - Plexa ICD lead

Other: Ilivia ICD Family - Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting

Other: Plexa ICD lead - Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting

Other: Ilivia ICD and Plexa lead - Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting


Treatment: Devices: Ilivia ICD Family
pre-defined device programming, measurements and follow-up schedule

Treatment: Devices: Plexa ICD lead
predefined follow-up schedule
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ilivia Family Related SADE-free Rate Through 3 Months
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Plexa Related SADE-free Rate Through 6 Months
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
Timepoint [3] 0 0
3 months

Eligibility
Key inclusion criteria
* Standard indication for ICD or CRT-D therapy according to clinical practice
* De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
* Patient is able to understand the nature of the clinical investigation and provides written informed consent
* Patient is able and willing to complete all routine study visits at the investigational site
* 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
* Contraindication to ICD or CRT-D therapy, respectively
* For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
* Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
* Expected to receive heart transplant or ventricular assist device within 6 months
* Life expectancy less than 6 months
* Participation in any other interventional clinical investigation
* Pregnant or breastfeeding at time of enrollment

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
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
NA
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
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2018
Sample size
Target
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Nambour
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
St. Pölten
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
France
State/province [3] 0 0
Brest
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Langensalza
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Oeynhausen
Country [6] 0 0
Germany
State/province [6] 0 0
Brandenburg
Country [7] 0 0
Germany
State/province [7] 0 0
Erlangen
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Freiburg
Country [10] 0 0
Germany
State/province [10] 0 0
Gera
Country [11] 0 0
Germany
State/province [11] 0 0
Kaiserslautern
Country [12] 0 0
Germany
State/province [12] 0 0
Singen
Country [13] 0 0
Germany
State/province [13] 0 0
Würzburg
Country [14] 0 0
Israel
State/province [14] 0 0
Ramat Gan
Country [15] 0 0
Israel
State/province [15] 0 0
Tel Aviv
Country [16] 0 0
Latvia
State/province [16] 0 0
Riga
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
San Sebastian
Country [20] 0 0
Spain
State/province [20] 0 0
Sevilla
Country [21] 0 0
Switzerland
State/province [21] 0 0
Basel
Country [22] 0 0
Switzerland
State/province [22] 0 0
Bern
Country [23] 0 0
Switzerland
State/province [23] 0 0
Luzern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Sticherling, Prof. Dr.
Address 0 0
Universitätsspital Basel
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT02774616