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

This study is currently recruiting participants.
Verified October 2011 by Sorin Group
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01410552
First received: August 3, 2011
Last updated: January 5, 2012
Last verified: October 2011
History of Changes

August 3, 2011
January 5, 2012
October 2011
October 2014   (final data collection date for primary outcome measure)
The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm enabled, are free from inappropriate shocks, compared to 92,5% of a general ICD population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01410552 on ClinicalTrials.gov Archive Site
  • The first secondary endpoint is to evaluate the percentage of appropriate shock (AS) episodes that are delivered over the 1-year follow-up (>68.6%) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Classify (origin and number) the unscheduled visits, the needs of reprogramming, of re-intervention, and of medication changes, and to determine the correlation with the percentage of inappropriate shock episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

Reduce inappropriate ICD shocks, that cause painful experience and have a detrimental effect on patient's quality of life, is still an important issue to be solved.

ISIS- ICD study has been designed to confirm that, with the PARAD+ algorithm, it is possible to have an increase of patients free from inappropriate shocks in a general population implanted for primary or secondary prevention with a dual or tri chamber device during one year follow-up
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
PARADYM ICD and CRT-d with PARAD+ algorithm available
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2016
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Signed and dated informed consent (according to the laws and regulations of the country in which the research is performed)

Exclusion Criteria:

  1. Any contraindication for ICD therapy
  2. Atrial lead not implanted
  3. Patient with permanent atrial tachyarrhythmia
  4. Post heart transplant or patients who are waiting for a heart transplant
  5. Patients implanted with a ventricular assist device (VAD)
  6. Already included in another clinical study that could confound the results of this study
  7. Inability to understand the purpose of the study or refusal to cooperate
  8. Unavailability for scheduled follow-up
  9. Less than 18 years of age
  10. Documented drug addiction or abuse that could interfere with study compliance
  11. Pregnancy
  12. Under guardianship
Both
18 Years and older
No
Contact: Mara Rolando 39 0161 487 448 mara.rolando@sorin.com
United States,   United Kingdom
 
NCT01410552
ISIS ICD - ITSY09
Not Provided
Dr. Ricardo RUIZ GRANELL /Principal investigator, Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
Sorin Group
Not Provided
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)
Sorin Group
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP