Trials / Completed
CompletedNCT01410552
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,013 (actual)
- Sponsor
- MicroPort CRM · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PARADYM 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 |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2015-08-01
- Completion
- 2016-02-01
- First posted
- 2011-08-05
- Last updated
- 2019-03-22
- Results posted
- 2018-02-12
Locations
80 sites across 7 countries: United States, France, Germany, Italy, Japan, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01410552. Inclusion in this directory is not an endorsement.