Heart Failure, Tachyarrhythmia
Conditions
Brief summary
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
Interventions
DEVICEIlivia ICD Family
pre-defined device programming, measurements and follow-up schedule
DEVICEPlexa ICD lead
predefined follow-up schedule
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Standard indication for ICD or CRT-D therapy according to clinical practice * De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant * Patient is able to understand the nature of the clinical investigation and provides written informed consent * Patient is able and willing to complete all routine study visits at the investigational site * Patient accepts Home Monitoring concept * Age ≥ 18 years
Exclusion criteria
* Contraindication to ICD or CRT-D therapy, respectively * For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient * Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary. * Expected to receive heart transplant or ventricular assist device within 6 months * Life expectancy less than 6 months * Participation in any other interventional clinical investigation * Pregnant or breastfeeding at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ilivia Family Related SADE-free Rate Through 3 Months | 3 months | This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device |
| Plexa Related SADE-free Rate Through 6 Months | 6 months | This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the Plexa lead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up | 6 months | Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by ATP-one-shot, the percentage of patients with at least one successful termination will be determined |
| Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up | 3 months | The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate |
| Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up | 3 months | The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate |
Countries
Australia, Austria, Denmark, France, Germany, Israel, Latvia, Singapore, Spain, Switzerland
Participant flow
Recruitment details
292 patients completed the informed consent process and signed the informed consent sheet.
Pre-assignment details
278 patients received one or more study devices implanted. 14 enrolled patients did not receive a study device and were excluded from the analysis. Reasons were implantation of other devices than the study devices (N = 8), no implantation of any device for different reasons (N = 5), or withdrawal of consent before implantation (N = 1).
Participants by arm
| Arm | Count |
|---|---|
| Ilivia ICD Family Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule | 95 |
| Plexa ICD Lead Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Plexa ICD lead: predefined follow-up schedule | 167 |
| Ilivia ICD and Plexa ICD Lead Implant of the new Ilivia ICD Family and the new Plexa ICD lead. Device measurements, pre-defined programming and Adverse Event Reporting
Pre-defined device programming, measurements and follow-up schedule | 16 |
| Total | 278 |
Baseline characteristics
| Characteristic | Ilivia ICD Family | Plexa ICD Lead | Ilivia ICD and Plexa ICD Lead | Total |
|---|---|---|---|---|
| Age, Continuous | 68 years | 64 years | 71 years | 65 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 29 Participants | 5 Participants | 51 Participants |
| Sex: Female, Male Male | 78 Participants | 138 Participants | 11 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 111 | 6 / 183 |
| other Total, other adverse events | 52 / 111 | 49 / 183 |
| serious Total, serious adverse events | 48 / 111 | 56 / 183 |
Outcome results
Primary
Ilivia Family Related SADE-free Rate Through 3 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
Time frame: 3 months
Population: These are all patients who either had a primary endpoint or who had reached 3 months of follow-up, or both.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilivia Arm | Ilivia Family Related SADE-free Rate Through 3 Months | 91 Participants |
| Ilivia ICD and Plexa ICD Lead | Ilivia Family Related SADE-free Rate Through 3 Months | 12 Participants |
Comparison: Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family 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: 0.0004exact binomial
Primary
Plexa Related SADE-free Rate Through 6 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the Plexa lead
Time frame: 6 months
Population: These are all patients who either had an endpoint or who reached 6 months of follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilivia Arm | Plexa Related SADE-free Rate Through 6 Months | 133 Participants |
| Ilivia ICD and Plexa ICD Lead | Plexa Related SADE-free Rate Through 6 Months | 12 Participants |
Comparison: Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-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: 0.0019exact binomial
Secondary
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by ATP-one-shot, the percentage of patients with at least one successful termination will be determined
Time frame: 6 months
Population: Only 5 patients had spontaneous ventricular arrhythmia detected in the VF zone.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilivia Arm | Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up | 1 Participants |
Secondary
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
Time frame: 3 months
Population: Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilivia Arm | Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up | 150 Participants |
Comparison: This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%p-value: <0.0001exact binomial
Secondary
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
Time frame: 3 months
Population: Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilivia Arm | Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up | 145 Participants |
p-value: <0.0001exact binomial