An interventional study of Ilivia ICD Family and Plexa ICD lead in Heart Failure and Tachyarrhythmia, sponsored by Biotronik SE & Co. KG. Completed at 25 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by Biotronik SE & Co. KG · Not applicable, Interventional, and Other
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
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 292 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Device: Ilivia ICD Family
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Device: Plexa ICD lead
Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
Device: Ilivia ICD Family · Device: Plexa ICD lead
pre-defined device programming, measurements and follow-up schedule
predefined follow-up schedule
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
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
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
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
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
292 patients completed the informed consent process and signed the informed consent sheet.
| Milestone | Ilivia ICD Family | Plexa ICD Lead | Ilivia ICD and Plexa ICD Lead |
|---|---|---|---|
| Started | 95 | 167 | 16 |
| Died | 6 | 3 | 1 |
| Withdrew consent | 3 | 3 | 0 |
| Lost to fu | 2 | 0 | 0 |
| Device explanted | 2 | 1 | 1 |
| Other | 2 | 4 | 1 |
| Completed | 80 | 156 | 13 |
| Not completed | 15 | 11 | 3 |
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
| Participants | Ilivia Arm | Ilivia ICD and Plexa ICD Lead |
|---|---|---|
| Ilivia Family Related SADE-free Rate Through 3 Months | 91 | 12 |
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
| Participants | Plexa Arm | Ilivia ICD and Plexa ICD Lead |
|---|---|---|
| Plexa Related SADE-free Rate Through 6 Months | 133 | 12 |
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
| Participants | Ilivia Arm |
|---|---|
| Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up | 1 |
The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
| Participants | Plexa Arm |
|---|---|
| Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up | 145 |
The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
| Participants | Plexa Arm |
|---|---|
| Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up | 150 |
Collected over Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ilivia ICD Family | 6/111 (5.4%) | 48/111 (43.2%) | 52/111 (46.8%) |
| Plexa ICD Lead | 6/183 (3.3%) | 56/183 (30.6%) | 49/183 (26.8%) |
| Event | Ilivia ICD Family | Plexa ICD Lead |
|---|---|---|
| decompensated heart failure/ cardiac decompensationCardiac disorders | 9/111 | 6/183 |
| Device issueGeneral disorders | 8/111 | 9/183 |
| Atrial fibrillationCardiac disorders | 6/111 | 5/183 |
| Heart failureCardiac disorders | 3/111 | 7/183 |
| HypotensionVascular disorders | 4/111 | 1/183 |
| Renal failureRenal and urinary disorders | 4/111 | 4/183 |
| Adverse drug reactionGeneral disorders | 3/111 | 6/183 |
| COPDRespiratory, thoracic and mediastinal disorders | 3/111 | 3/183 |
| Gastrointestinal disorders NECGastrointestinal disorders | 3/111 | 3/183 |
| Musculoskeletal and connective tissue disorder NECMusculoskeletal and connective tissue disorders | 3/111 | 1/183 |
| Event | Ilivia ICD Family | Plexa ICD Lead |
|---|---|---|
| Inappropriate phrenic nerve stimulationGeneral disorders | 12/111 | 7/183 |
| Device issueGeneral disorders | 8/111 | 5/183 |
| Adverse drug reactionGeneral disorders | 4/111 | 7/183 |
| Allergic reactionImmune system disorders | 4/111 | 2/183 |
| Ventricular tachycardiaCardiac disorders | 4/111 | 4/183 |
| Wound complicationInjury, poisoning and procedural complications | 4/111 | 3/183 |
| Atrial fibrillationCardiac disorders | 3/111 | 3/183 |
| General disorders and administration site conditions NECGeneral disorders | 3/111 | 1/183 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) NECNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/111 | 2/183 |
| PruritusSkin and subcutaneous tissue disorders | 3/111 | 0/183 |
| Age, Continuous(years) | Ilivia ICD Family | Plexa ICD Lead | Ilivia ICD and Plexa ICD Lead | Total |
|---|---|---|---|---|
| Median | 68 (56 to 74) | 64 (57 to 72) | 71 (58 to 74.5) | 65 (57 to 73) |
| Sex: Female, Male(Participants) | Ilivia ICD Family | Plexa ICD Lead | Ilivia ICD and Plexa ICD Lead | Total |
|---|---|---|---|---|
| Female | 17 | 29 | 5 | 51 |
| Male | 78 | 138 | 11 | 227 |
| Race and Ethnicity Not Collected(Participants) | Ilivia ICD Family | Plexa ICD Lead | Ilivia ICD and Plexa ICD Lead | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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Plan to share: No
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Biotronik SE & Co. KG