Heart Failure, Tachyarrhythmia
Conditions
Brief summary
Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.
Interventions
DEVICEActicor/Rivacor ICDs/CRT-Ds
pre-defined device programming, measurements and follow-up schedule
DEVICEPlexa S DX
Implantation, measurements and follow-up schedule
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Standard indication for ICD or CRT-D therapy according to clinical guidelines * Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant * Able to understand the nature of study and to provide written informed consent * Willing and able to perform all follow-up visits at the study site * Willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
Exclusion criteria
* Contraindication to ICD and CRT-D therapy * Planned for implantation of a CRT-DX system * For VR-T DX devices: permanent atrial tachyarrhythmia * For VR-T DX devices: patients requiring atrial pacing * Less than 18 years old * Pregnant or breast feeding * Participating in another interventional clinical investigation * Life-expectancy is less than 12 months * Cardiac surgical procedure planned within 12 months after implantation (including interventional procedures like ablation, valve replacement, heart transplant etc.). Procedures to occur during or prior to implantation are not exclusionary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up | 3 months | Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate | 3 months, 12 months | Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate |
| Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | 3 months | Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor. |
| Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | 3 months | Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor. |
Countries
Austria, Germany, Hungary, Latvia, Netherlands, Slovakia, Switzerland
Participant flow
Recruitment details
130 patients completed the informed consent process and signed the informed consent sheet.
Pre-assignment details
127 patients received one or more study devices implanted. 3 enrolled patients did not receive a study device. Two of those patients who did not receive a study were excluded from the analysis while the third patient underwent an implantation attempt and was therefore included in the general analysis population
Participants by arm
| Arm | Count |
|---|---|
| Acticor/Rivacor ICDs/CRT-Ds Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Device explanted | 3 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | No study device implanted | 3 |
| Overall Study | Physician Decision | 4 |
Baseline characteristics
| Characteristic | Acticor/Rivacor ICDs/CRT-Ds | — |
|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 9.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 13 participants | — |
| Region of Enrollment Germany | 27 participants | — |
| Region of Enrollment Hungary | 24 participants | — |
| Region of Enrollment Latvia | 17 participants | — |
| Region of Enrollment Netherlands | 21 participants | — |
| Region of Enrollment Slovakia | 4 participants | — |
| Region of Enrollment Switzerland | 22 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 102 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 130 |
| other Total, other adverse events | 42 / 130 |
| serious Total, serious adverse events | 54 / 130 |
Outcome results
Primary
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
Time frame: 3 months
Population: All patients who either had a primary endpoint or who had reached 3 months of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up | 122 Participants |
Comparison: Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%p-value: 0.0595% CI: [0.9, 1]t-test, 2 sided
Secondary
Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate
Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate
Time frame: 3 months, 12 months
Population: Of 130 enrolled patients, 127 implanted with a COR Family ICD. Out of these, 123 patients were eligible for these endpoint analysis; 4 patients had premature study termination before day 61 after implantation without experiencing a Serious Adverse Device Effect related to the Cor Family device (SADE-d) and were excluded from analysis. For the 12-month endpoint, 111 patients who completed the study were eligible for endpoint analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate | 99.2 percentage of participants |
| Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation | Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate | 99.2 percentage of participants |
Secondary
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor.
Time frame: 3 months
Population: In total, 20 assessments were received from the investigator at the time of the 3-month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Very good | 7 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Good | 10 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Adequate | 3 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Poor | 0 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Very poor | 0 Handling-assessment by investigator |
Secondary
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor.
Time frame: 3 months
Population: In total, 52 assessments were received from the investigators: 24 assessments at time of implantation, 21 assessments at time of pre-hospital discharge, 7 assessments during 3-month follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Very good | 21 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Good | 27 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Adequate | 3 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Poor | 1 Handling-assessment by investigator |
| Acticor/Rivacor ICDs/CRT-Ds | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Very poor | 0 Handling-assessment by investigator |