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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renamic Neo programmer device, including software; PK-222-L ECG cable | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are planned to receive or are already implanted with a programmable BIOTRONIK cardiac rhythm management (CRM) device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | Australia | ||||
| GenesisCare Wesley |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implantation and Follow-up Use Cases | Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implantation and Follow-up Use Cases | Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Units | use cases for Renamic Neo | 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). | use cases for Renamic Neo | use cases for Renamic Neo |
Implantations (Days): Mean: 1.0; SD: SD:1.6 Follow-up (Days) : Mean:1.1 SD: 6.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implantation and Follow-up Use Cases | Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complete heart block | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Project Management | BIOTRONIK SE & Co.KG | +49 30 68905 | 0 | mathias.freudigmann@biotronik.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2019 | Mar 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2020 | Mar 14, 2022 | SAP_001.pdf |
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| Auchenflower |
| Australia |
| GenesisCare Bundaberg | Bundaberg | Australia |
| The Canberra Hospital | Canberra | Australia |
| Lyell McEwin Hospital (LMH) | Elizabeth Vale | Australia |
| Monash Medical Centre | Melbourne | Australia |
| Mulgrave Private Hospital | Mulgrave | Australia |
| John Hunter Hospital | New Lambton Heights | Australia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Height [cm] | Mean | Standard Deviation | cm |
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| Weight [kg] | Mean | Standard Deviation | kg |
|
| ID | Title | Description |
|---|
| OG000 | Implantation and Follow-up Use Cases | Implantation use cases include PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases |
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| 0 |
| 110 |
| 0 |
| 110 |
| 1 |
| 110 |
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