Tachycardia
Conditions
Keywords
Primary prevention, Secondary prevention
Brief summary
ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up
Detailed description
The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.
Interventions
DEVICEPARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
PARADYM ICD and CRT-d with PARAD+ algorithm available
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
ICD device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days 2. Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months
Exclusion criteria
1. Any contraindication for ICD therapy 2. Atrial lead not implanted 3. Patient with permanent atrial tachyarrhythmia 4. Patients implanted with a ventricular assist device (VAD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Inappropriate Shock(s) | 552 days | Percentage of patients presenting with inappropriate shock(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shock(s) Appropriately Delivered | 552 days | Percentage of shocks appropriately delivered |
Countries
France, Germany, Italy, Japan, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm ICD or CRT-D with PARAD+ | 993 |
| Total | 993 |
Baseline characteristics
| Characteristic | Single Arm | — |
|---|---|---|
| Age, Continuous | 68.0 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 204 Participants | — |
| Sex: Female, Male Male | 789 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 70 / 1,013 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 282 / 1,013 |
Outcome results
Primary
Patients With Inappropriate Shock(s)
Percentage of patients presenting with inappropriate shock(s)
Time frame: 552 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Patients With Inappropriate Shock(s) | 1.4 Percentage of pts with inap shocks |
Secondary
Shock(s) Appropriately Delivered
Percentage of shocks appropriately delivered
Time frame: 552 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Shock(s) Appropriately Delivered | 73.7 Percentage of appropriate shocks |