Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination (ISIS-ICD)
This study is currently recruiting participants.
Verified October 2011 by Sorin Group
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01410552
First received: August 3, 2011
Last updated: January 5, 2012
Last verified: October 2011
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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:
- Any contraindication for ICD therapy
- Atrial lead not implanted
- Patient with permanent atrial tachyarrhythmia
- Post heart transplant or patients who are waiting for a heart transplant
- Patients implanted with a ventricular assist device (VAD)
- Already included in another clinical study that could confound the results of this study
- Inability to understand the purpose of the study or refusal to cooperate
- Unavailability for scheduled follow-up
- Less than 18 years of age
- Documented drug addiction or abuse that could interfere with study compliance
- Pregnancy
- 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 May 21, 2013