Status:
COMPLETED
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Lead Sponsor:
MicroPort CRM
Conditions:
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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.
Eligibility Criteria
Inclusion
- 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
- Any contraindication for ICD therapy
- Atrial lead not implanted
- Patient with permanent atrial tachyarrhythmia
- Patients implanted with a ventricular assist device (VAD)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
1013 Patients enrolled
Trial Details
Trial ID
NCT01410552
Start Date
October 1 2011
End Date
February 1 2016
Last Update
March 22 2019
Active Locations (80)
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1
Southwest Cardiovascular Associates
Mesa, Arizona, United States, 85205
2
Pacific Arrhythmia Services
Mesa, Arizona, United States, 91942
3
Banner Arizona Medical Clinic
Peoria, Arizona, United States, 85381
4
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006