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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410552
First Posted: August 5, 2011
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LivaNova
  Purpose
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 Intervention 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 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

Resource links provided by NLM:


Further study details as provided by LivaNova:

Primary Outcome Measures:
  • Percentage of patient with inappropriate shock [ Time Frame: 1 year ]
    device based data


Secondary Outcome Measures:
  • Appropriate shock [ Time Frame: 1 year ]
    device based data


Enrollment: 1013
Study Start Date: October 2011
Study Completion Date: February 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 80 Study Locations
Sponsors and Collaborators
LivaNova
Investigators
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

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01410552     History of Changes
Other Study ID Numbers: ISIS ICD - ITSY09
First Submitted: August 3, 2011
First Posted: August 5, 2011
Last Update Posted: November 13, 2017
Last Verified: November 2016

Keywords provided by LivaNova:
Primary prevention
Secondary prevention

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes