The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02774616
Ethics application status
Date submitted
13/05/2016
Date registered
17/05/2016
Date last updated
22/05/2019

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 - This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Plexa Related SADE-free Rate Through 6 Months - This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
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 - Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up - The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up - The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
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
Gender
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
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
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
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
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right
ventricular lead to fulfill requirements by the notified body and to support regulatory
approval outside of the CE region
Trial website
https://clinicaltrials.gov/show/NCT02774616
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

Summary results
Other publications