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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01410552
First received: August 3, 2011
Last updated: February 23, 2015
Last verified: February 2015
  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: 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 Sorin Group:

Primary Outcome Measures:
  • Percentage of patient with inappropriate shock [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    device based data


Secondary Outcome Measures:
  • Appropriate shock [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    device based data


Enrollment: 1013
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410552

  Show 80 Study Locations
Sponsors and Collaborators
Sorin Group
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

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01410552     History of Changes
Other Study ID Numbers: ISIS ICD - ITSY09
Study First Received: August 3, 2011
Last Updated: February 23, 2015
Health Authority: United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sorin Group:
Primary prevention
Secondary prevention

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

ClinicalTrials.gov processed this record on May 29, 2015