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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04350008




Registration number
NCT04350008
Ethics application status
Date submitted
14/04/2020
Date registered
16/04/2020

Titles & IDs
Public title
BIO|CONCEPT.Renamic Neo Study
Scientific title
BIO|CONCEPT.Renamic Neo
Secondary ID [1] 0 0
BA112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical Devices 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Renamic Neo programmer device, including software; PK-222-L ECG cable

Treatment: Devices: Renamic Neo programmer device, including software; PK-222-L ECG cable
Patients were enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients were included for follow-ups only. Implants were programmed and interrogated by using the investigational devices.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases
Assessment method [1] 0 0
The number of Adverse Device Effects (ADE) and Device Deficiencies (DD) that occured in patients, users or other persons during the use of the Renamic Neo programmer at implantation, pre-hospital discharge and during the on-site follow-up was evaluated. The investigator was asked to report any ADEs or DD that occurred during implantations and follow-ups. All Adverse Device Effects (ADE) related to the investigational device and only Device Deficiencies (DD) that were determined to bear the potential for a medical occurrence were prespecified to be collected.
Timepoint [1] 0 0
Patients participated from (I) implantation until the pre-hospital discharge (usually 1-2 days) or (II) only for the in-office follow-up (usually 1 day).

Eligibility
Key inclusion criteria
* Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device.
* Patient is able to understand the nature of the study and provides written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is implanted with a Stratos pacemaker.
* Patient is planned for implant exchange or upgrade.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2020
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
GenesisCare Wesley - Auchenflower
Recruitment hospital [3] 0 0
GenesisCare Bundaberg - Bundaberg
Recruitment hospital [4] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [5] 0 0
Lyell McEwin Hospital (LMH) - Elizabeth Vale
Recruitment hospital [6] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [7] 0 0
Mulgrave Private Hospital - Mulgrave
Recruitment hospital [8] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
- Bundaberg
Recruitment postcode(s) [4] 0 0
- Canberra
Recruitment postcode(s) [5] 0 0
- Elizabeth Vale
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Mulgrave
Recruitment postcode(s) [8] 0 0
- New Lambton Heights

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik Australia Pty Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04350008