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
  Purpose

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


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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: October 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Contacts
Contact: Mara Rolando 39 0161 487 448 mara.rolando@sorin.com

Locations
United States, Arizona
Banner Arizona Medical Clinic Recruiting
Peoria, Arizona, United States, 85381
Contact: Khawaja Tareq A., Doctor         
Principal Investigator: Khawaja Tareq A., Doctor         
Banner Good Samaritan Medical Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: Nafisi Sina, Doctor         
Principal Investigator: Nafisi Sina, Doctor         
United States, New York
Harlem Cardiology Recruiting
New York City, New York, United States, 10035
Contact: Saint-Jacques Henock, Doctor         
Principal Investigator: Saint-Jacques Henock, Doctor         
United States, Ohio
The Toledo Hospital Recruiting
Toledo, Ohio, United States, 43615
Contact: Richards Mark, Doctor         
Principal Investigator: Richards Mark, Doctor         
United States, Pennsylvania
Easton Hospital Recruiting
Easton, Pennsylvania, United States, 18042
Contact: Khalighi Koroush, Doctor         
Principal Investigator: Khalighi Koroush, Doctor         
United States, South Carolina
Medical University of South Carolina Recruiting
Charlestone, South Carolina, United States, 29403
Contact: Leman Robert, Doctor         
Principal Investigator: Leman Robert, Doctor         
Providence Hospital Recruiting
Columbia, South Carolina, United States, 29204
Contact: Malanuk Robert, Doctor         
Principal Investigator: Malanuk Robert, Doctor         
Carolina Arrhythmia Consultants Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Frain Bryan, Doctor         
Principal Investigator: Frain Bryan, Doctor         
United Kingdom
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16
Contact: Harris Stuart, Doctor         
Principal Investigator: Harris Stuart, Doctor         
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: Dr. Ricardo RUIZ GRANELL /Principal investigator, Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
ClinicalTrials.gov Identifier: NCT01410552     History of Changes
Other Study ID Numbers: ISIS ICD - ITSY09
Study First Received: August 3, 2011
Last Updated: January 5, 2012
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014