heart rhythm disorders
Conditions
Interventions
None listed
Sponsors
Microport CRM B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Indication for an ICD or CRT-D implant, according to ESC guidelines. 2. Scheduled for a de novo implant of an ICD (VR, DR) or CRT-D, manufactured by Microport CRM, equipped with a DF4-connector. 3. Dated and signed Informed Consent.
Exclusion criteria
Exclusion criteria: 1. Tricuspid valvular disease, or tricuspid valve replacement of any kind. 2. Transient tachy-arhythmias due to reversible causes. 3. Contra-indication to a maximum single dose of 330 ug dexamethasone sodium phosphate (DSP). 4. Active myocarditis. 5.Previous implant of a pacemaker, ICD or CRT-D device and leads. 6. Enrolled in another study that may confound the results of the Apollo study. 7. Inability to understand the purpose of the study. 8. Under the age of 18. 9. Pre-menopausal women. 10. Drug addiction or drug abuse. 11. Life expectancy less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early safety and performance endpoint: • Freedom from Unanticipated Serious Adverse Device Effect (USADE) from RV lead, from attempt to implant to 1M. The endpoint will consider any serious adverse device effect which by its nature, incidence, severity or outcome was not identified in the risk analysis report. The anticipated patients* free-rate is 100%, against a priori performance goal of 95%. • Summarize RV pacing threshold amplitude (V), RV pacing impedance (Ohm), endocardial R wave amplitude (mV), defibrillation coil impedance (Ohm) at 1 month. The result of this analysis will not determine the success or failure of the study. This endpoint has been selected in order to grow a body of evidence (that starts with few pts at 1M, and ends with a large population at 2 years): the assessment of this analysis will be done by the Data Safety Monitoring Board (DSMB). The study will have 2 co-primary endpoints, assessed independently on the subjects enrolled in Phase I: • INVICTA lead safety at 3 months: freedom from RV lead-related complications that occurred up to 90 days from first attempt to implant the INVICTA lead. A complication is defined as any serious adverse event related to the INVICTA lead (SADE) that resulted in patient death or required an additional invasive intervention. Lead-related complications may occur during or after the implant procedure. The anticipated complication-free rate is 0.97, against a priori performance goal of 0.90. • INVICTA lead performance at 3 months: RV pacing threshold at 3 months from successful implant. The anticipated pacing threshold value is 1.0±0.5 V at 0.5 ms, against a priori performance goal of | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. INVICTA pacing threshold amplitude (V), RV pacing impedance (Ohm), endocardial R wave amplitude (mV), defibrillation coil impedance(Ohm) at Implant, pre-hospital discharge, 1 month, 3, 6, 12, 18 and 24 months after implant. 2. Efficacy of INVICTA leads to terminate ventricular tachycardia (VT) and/or ventricular fibrillation (VF) by endocardial shock therapies, when a defibrillation test is performed (at physician discretion) or a spontaneous ventricular arrhythmia occurs. 3. Acute INVICTA lead complications (30 days post-implant). 5. Daily INVICTA autothreshold values (V) from implant to M1 visit (applicable if implanted with an ICD model with auto-threshold feature enabled). 6. INVICTA lead handling assessment. 7. INVICTA lead implant success rate. 8. SAE's up to 24 months post implantation Tertiary endpoints: 1. Acute complication rates as a function of the lead position (apical vs septal, 30 days post-implantation). Electrical performances as a function of the lead position (apical vs septal), up to 24 months post-implantation | — |
Countries
Netherlands
Outcome results
None listed