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Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination (ISIS-ICD)

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ClinicalTrials.gov Identifier: NCT01410552
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : February 12, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort CRM

Study Description
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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

Condition or disease Intervention/treatment Phase
Tachycardia 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 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1013 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: ICD device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Study Start Date : October 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
ICD or CRT-D with PARAD+
only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator
 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


Outcome Measures
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Primary Outcome Measures :
  1. Patients With Inappropriate Shock(s) [ Time Frame: 552 days ]
    Percentage of patients presenting with inappropriate shock(s)


Secondary Outcome Measures :
  1. Shock(s) Appropriately Delivered [ Time Frame: 552 days ]
    Percentage of shocks appropriately delivered


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410552


Locations
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Sponsors and Collaborators
MicroPort CRM
Investigators
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Principal Investigator: Ricardo RUIZ GRANELL, Dr Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
Principal Investigator: Mark RICHARDS, Dr. Toledo Hospital, 4614 Brookside Dr. Toledo (OH)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MicroPort CRM
ClinicalTrials.gov Identifier: NCT01410552    
Other Study ID Numbers: ISIS ICD - ITSY09
First Posted: August 5, 2011    Key Record Dates
Results First Posted: February 12, 2018
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by MicroPort CRM:
Primary prevention
Secondary prevention
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes