Trial Outcomes & Findings for BIO|CONCEPT.Renamic Neo Study (NCT NCT04350008)
NCT ID: NCT04350008
Last Updated: 2022-09-16
Results Overview
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.
COMPLETED
110 participants
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).
2022-09-16
Participant Flow
Participant milestones
| Measure |
Implantation and Follow-up Use Cases
Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Implantation and Follow-up Use Cases
n=110 Participants
Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases.
|
|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 13.2 • n=110 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=110 Participants
|
|
Region of Enrollment
Australia
|
110 participants
n=110 Participants
|
|
Height [cm]
|
171.4 cm
STANDARD_DEVIATION 10.3 • n=110 Participants
|
|
Weight [kg]
|
84.5 kg
STANDARD_DEVIATION 19.2 • n=110 Participants
|
PRIMARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Implantation and Follow-up Use Cases
n=151 use cases for Renamic Neo
Implantation use cases include PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases
|
|---|---|
|
Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases
|
0 use cases for Renamic Neo
|
Adverse Events
Implantation and Follow-up Use Cases
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Implantation and Follow-up Use Cases
n=110 participants at risk
Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases
|
|---|---|
|
Cardiac disorders
Complete heart block
|
0.91%
1/110 • Number of events 1 • Implantations (Days): Mean: 1.0; SD: SD:1.6 Follow-up (Days) : Mean:1.1 SD: 6.0
|
Additional Information
Director Clinical Project Management
BIOTRONIK SE & Co.KG
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60