Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
- Conditions
- Tachycardia
- Interventions
- 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
- Registration Number
- NCT01410552
- Lead Sponsor
- MicroPort CRM
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1013
- 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
- Any contraindication for ICD therapy
- Atrial lead not implanted
- Patient with permanent atrial tachyarrhythmia
- Patients implanted with a ventricular assist device (VAD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICD or CRT-D with PARAD+ PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770 only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator
- Primary Outcome Measures
Name Time Method Patients With Inappropriate Shock(s) 552 days Percentage of patients presenting with inappropriate shock(s)
- Secondary Outcome Measures
Name Time Method Shock(s) Appropriately Delivered 552 days Percentage of shocks appropriately delivered
Trial Locations
- Locations (80)
Pitt Memeorial Hospital Heart Rhythm Associates
🇺🇸Greenville, North Carolina, United States
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Ospedale S.Andrea
🇮🇹Vercelli, Italy
Yokohama City University Hospital
🇯🇵Yokohama, Japan
Tokai University School of Medicine
🇯🇵Tokai, Japan
Kardiologische Praxis Dr. med Taggeselle
🇩🇪Markkleeberg, Germany
Chiba University Hospital
🇯🇵Chiba, Japan
Po Melorio
🇮🇹Santa Maria Capua Vetere, Italy
Yamanashi Prefectural Central Hospital
🇯🇵Kofu-city, Japan
Kokura Memorial Hospital
🇯🇵Kokura, Japan
CH Périgueux
🇫🇷Périgueux, France
Policlinico Consorziale di Bari U.O Cardiologia Universitaria
🇮🇹Bari, Italy
Ichinomiya Nishi Hospital
🇯🇵Ichinomiya City, Japan
Yamaguchi University Hospital
🇯🇵Ube City, Japan
Centre Hospitalier
🇫🇷PAU, France
CHU Brabois
🇫🇷Vandoeuvre Les Nancy, France
Universitatsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
🇩🇪Lüneburg, Germany
Iizuka Hospital
🇯🇵Iizuka City, Japan
Shin-Tokyo Hospital
🇯🇵Tokyo, Japan
Kettering Hospital
🇬🇧Kettering, United Kingdom
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Papworth Everard
🇬🇧Cambridge, United Kingdom
Centre Hospitalier de Valence
🇫🇷Valence, France
Hospital Universitario La Paz
🇪🇸Madrid, Spain
DRK Krankenhaus Ratzeburg
🇩🇪Ratzeburg, Germany
Klinikum Bogenhausen
🇩🇪Bogenhausen, Germany
Ohtanishinouchi Hospital
🇯🇵Koriyama City, Japan
Yokohama Rosai general Hospital
🇯🇵Yokosuka City, Japan
UKSH Campus Luebeck
🇩🇪Luebeck, Germany
CHU VIGO
🇪🇸Vigo, Spain
CH Yves le Foll
🇫🇷Saint-Brieuc, France
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
Hospital Universitario de la Ribera
🇪🇸Alzira, Spain
Tokyo Medical and Dental University Hospital
🇯🇵Tokyo, Japan
Tokyo Metropolitan Hiroo Hospital
🇯🇵Tokyo, Japan
Southwest Cardiovascular Associates
🇺🇸Mesa, Arizona, United States
Southern California Electrophysiology Associates
🇺🇸Anaheim, California, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
H. Raj Reddy Md, Inc.
🇺🇸Hanford, California, United States
St. Rose Hospital
🇺🇸Fremont, California, United States
Raymond H. M. Schaerf MD, Inc.
🇺🇸Burbank, California, United States
Memorial West Hospital
🇺🇸Pembroke Pines, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
St. Tammany Hospital
🇺🇸Covington, Louisiana, United States
Louisiana Heart Center
🇺🇸Slidell, Louisiana, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
MGH
🇺🇸Boston, Massachusetts, United States
Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Harlem Cardiology
🇺🇸New York, New York, United States
Rex Heart and Vascular Specialists
🇺🇸Raleigh, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Easton Hospital
🇺🇸Easton, Pennsylvania, United States
Providence Hospital
🇺🇸Columbia, South Carolina, United States
Carolina Arrhythmia Consultants
🇺🇸Mount Pleasant, South Carolina, United States
Centre Hospitalier Universitaire D'Amiens
🇫🇷Amiens, France
Clinique Saint Joseph
🇫🇷Angers, France
Chu Annecy
🇫🇷Annecy, France
CH Henri Duffaut - Avignon
🇫🇷Avignon, France
CHRU du Morvan Hôpital la Cavale Blanche
🇫🇷Brest, France
Hôpital Privé de Bois Bernad
🇫🇷Bois Bernard, France
Hôpital Instruction des Armées
🇫🇷Clamart, France
CH LENS
🇫🇷Lens, France
CH La Rochelle - hôpital St Louis
🇫🇷La Rochelle, France
Hopital Saint Joseph et saint Luc
🇫🇷Lyon, France
Centre Hospitalier Universitaire de La Timone
🇫🇷Marseille, France
Hopital Nord
🇫🇷Marseille, France
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CHU Groupe Hospitalo-universitaire Caremeau
🇫🇷Nimes, France
CH Montpellier
🇫🇷Montpellier, France
CH Emile Muller
🇫🇷Mulhouse, France
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Pacific Arrhythmia Services
🇺🇸Mesa, Arizona, United States
Banner Arizona Medical Clinic
🇺🇸Peoria, Arizona, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Gulfport Memorial Hospital
🇺🇸Gulfport, Mississippi, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States