Medical DevicesNCT04350008

BIO|CONCEPT.Renamic Neo Study

An observational study of Medical Devices, run by Biotronik Australia Pty Ltd. at 8 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Medical Devices
What is being tested?: Renamic Neo programmer device, including software; PK-222-L ECG cable
Type of treatment: Medical device
How many people: 110 participants
Where: 8 sitesAustralia
Study dates: 8 Jun 2020to 29 Oct 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients that are planned to receive or are already implanted with a programmable BIOTRONIK cardiac rhythm management (CRM) device.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Australia8 sites

Royal Adelaide Hospital
Adelaide
GenesisCare Wesley
Auchenflower
GenesisCare Bundaberg
Bundaberg
The Canberra Hospital
Canberra
Lyell McEwin Hospital (LMH)
Elizabeth Vale
Monash Medical Centre
Melbourne
Mulgrave Private Hospital
Mulgrave
John Hunter Hospital
New Lambton Heights

Other trials in Australia

About this study

Official title: BIO|CONCEPT.Renamic Neo

The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.

Conditions: Medical Devices
Being tested: Renamic Neo programmer device, including software; PK-222-L ECG cable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renamic Neo programmer device, including software; PK-222-L ECG cableDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202029 Oct 2020

First posted16 Apr 2020
Study start8 Jun 2020
Primary completion29 Oct 2020
Study completion29 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Medical DevicesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04350008
Sponsor's protocol ID: BA112
Status last verified: May 2020
First submitted: 14 Apr 2020
Last updated: 16 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Medical Devices trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BIO|CONCEPT.Renamic Neo
ClinicalTrials.gov ID: NCT04350008
Acronym / sponsor ID: BA112
Conditions: Medical Devices
Study type: Observational
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Biotronik Australia Pty Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jun 2020 (actual)
Primary completion: 29 Oct 2020 (actual)
Study completion: 29 Oct 2020 (actual)
First posted: 16 Apr 2020 (actual)
Results: Posted 16 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients that are planned to receive or are already implanted with a programmable BIOTRONIK cardiac rhythm management (CRM) device.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Renamic Neo programmer device, including software; PK-222-L ECG cablePatients 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.	Device	–

Primary outcome

Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases
Time frame: 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).
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.

Results and safety

Results posted to the registry on 16 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implantation and Follow-up Use Cases	110	110

Primary outcome: Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases

Time frame: 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).. Count of units. Unit: use cases for Renamic Neo

Measure	Implantation and Follow-up Use Cases n = 110
Value	0

Population analysed: Analysed were 49 implantation use cases and 102 follow-up use cases which include interrogations at pre-hospital discharge. Analysed were all implantation, pre-hospital discharge and follow-up cases for which the Renamic Neo programmer was used.

Adverse events

Time frame: Implantations (Days): Mean: 1.0; SD: SD:1.6 Follow-up (Days) : Mean:1.1 SD: 6.0. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implantation and Follow-up Use Cases	0 of 110 (0%)	1 of 110 (0.9%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Medical Devices

RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
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Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Medical Devices, run by Biotronik Australia Pty Ltd. at 8 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.