N/A
N=1,013
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT01410552 ↗Enrolled (actual)
1,013
Serious AEs
27.8%
Results posted
Feb 2018
Primary outcome: Primary: Patients With Inappropriate Shock(s) — 1.4 Percentage of pts with inap shocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MicroPort CRM
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Inappropriate Shock(s) |
1.4 | — |
| SECONDARY Shock(s) Appropriately Delivered |
73.7 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- 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
- Any contraindication for ICD therapy
- Atrial lead not implanted
- Patient with permanent atrial tachyarrhythmia
- Patients implanted with a ventricular assist device (VAD)
Data sourced from ClinicalTrials.gov (NCT01410552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.