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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
BIO|MASTER.Ilivia Family / Plexa
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Secondary ID [1]
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TA111
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Tachyarrhythmia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ilivia Family Related SADE-free Rate Through 3 Months
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Assessment method [1]
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This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
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Timepoint [1]
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3 months
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Primary outcome [2]
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Plexa Related SADE-free Rate Through 6 Months
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Assessment method [2]
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This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
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Timepoint [2]
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6 months
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Secondary outcome [1]
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Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
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Assessment method [1]
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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
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
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Assessment method [2]
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The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
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Timepoint [2]
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3 months
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Secondary outcome [3]
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Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
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Assessment method [3]
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The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
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Timepoint [3]
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3 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2018
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Sample size
Target
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Accrual to date
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Final
292
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Nambour General Hospital - Nambour
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Recruitment postcode(s) [1]
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- Liverpool
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Recruitment postcode(s) [2]
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- Nambour
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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St. Pölten
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Country [2]
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Denmark
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State/province [2]
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Odense
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Country [3]
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France
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State/province [3]
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Brest
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Country [4]
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Germany
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State/province [4]
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Bad Langensalza
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Country [5]
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Germany
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State/province [5]
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Bad Oeynhausen
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Country [6]
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Germany
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State/province [6]
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Brandenburg
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Country [7]
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Germany
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State/province [7]
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Erlangen
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Country [8]
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Germany
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State/province [8]
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Essen
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Country [9]
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Germany
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State/province [9]
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Freiburg
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Country [10]
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Germany
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State/province [10]
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Gera
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Country [11]
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Germany
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State/province [11]
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Kaiserslautern
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Country [12]
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Germany
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State/province [12]
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Singen
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Country [13]
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Germany
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State/province [13]
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Würzburg
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Country [14]
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Israel
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State/province [14]
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Ramat Gan
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Country [15]
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Israel
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State/province [15]
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Tel Aviv
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Country [16]
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Latvia
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State/province [16]
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Riga
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Country [17]
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Singapore
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State/province [17]
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Singapore
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Country [18]
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Spain
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State/province [18]
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Barcelona
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Country [19]
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Spain
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State/province [19]
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San Sebastian
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Country [20]
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Spain
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State/province [20]
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Sevilla
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Country [21]
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Switzerland
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State/province [21]
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Basel
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Country [22]
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Switzerland
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State/province [22]
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Bern
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Country [23]
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Switzerland
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State/province [23]
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Luzern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik SE & Co. KG
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Address
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Country
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02774616
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christian Sticherling, Prof. Dr.
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Address
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Universitätsspital Basel
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02774616
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