Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
NCT ID: NCT01410552
Last Updated: 2019-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1013 participants
INTERVENTIONAL
2011-10-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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 Criteria
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Inclusion Criteria
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
2. Atrial lead not implanted
3. Patient with permanent atrial tachyarrhythmia
4. Patients implanted with a ventricular assist device (VAD)
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Ricardo RUIZ GRANELL, Dr
Role: PRINCIPAL_INVESTIGATOR
Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
Mark RICHARDS, Dr.
Role: PRINCIPAL_INVESTIGATOR
Toledo Hospital, 4614 Brookside Dr. Toledo (OH)
Locations
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Southwest Cardiovascular Associates
Mesa, Arizona, United States
Pacific Arrhythmia Services
Mesa, Arizona, United States
Banner Arizona Medical Clinic
Peoria, Arizona, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Southern California Electrophysiology Associates
Anaheim, California, United States
Raymond H. M. Schaerf MD, Inc.
Burbank, California, United States
St. Rose Hospital
Fremont, California, United States
H. Raj Reddy Md, Inc.
Hanford, California, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial West Hospital
Pembroke Pines, Florida, United States
Medical Center of Central Georgia
Macon, Georgia, United States
University of Chicago
Chicago, Illinois, United States
St. Tammany Hospital
Covington, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Louisiana Heart Center
Slidell, Louisiana, United States
MGH
Boston, Massachusetts, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, United States
Harlem Cardiology
New York, New York, United States
Pitt Memeorial Hospital Heart Rhythm Associates
Greenville, North Carolina, United States
Rex Heart and Vascular Specialists
Raleigh, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Easton Hospital
Easton, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Providence Hospital
Columbia, South Carolina, United States
Carolina Arrhythmia Consultants
Mt. 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
Hôpital Privé de Bois Bernad
Bois-Bernard, , France
CHRU du Morvan Hôpital la Cavale Blanche
Brest, , France
Hôpital Instruction des Armées
Clamart, , France
CH La Rochelle - hôpital St Louis
La Rochelle, , France
CH LENS
Lens, , France
Hopital Saint Joseph et saint Luc
Lyon, , France
Centre Hospitalier Universitaire de La Timone
Marseille, , France
Hopital Nord
Marseille, , France
CH Montpellier
Montpellier, , France
CH Emile Muller
Mulhouse, , France
CHU Groupe Hospitalo-universitaire Caremeau
Nîmes, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Centre Hospitalier
Pau, , France
CH Périgueux
Périgueux, , France
CH Yves le Foll
Saint-Brieuc, , France
Centre Hospitalier de Valence
Valence, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Klinikum Bogenhausen
Bogenhausen, , Germany
Universitatsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, , Germany
UKSH Campus Luebeck
Lübeck, , Germany
Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
Lüneburg, , Germany
Kardiologische Praxis Dr. med Taggeselle
Markkleeberg, , Germany
DRK Krankenhaus Ratzeburg
Ratzeburg, , Germany
Policlinico Consorziale di Bari U.O Cardiologia Universitaria
Bari, , Italy
Po Melorio
Santa Maria Capua Vetere, , Italy
Ospedale S.Andrea
Vercelli, , Italy
Chiba University Hospital
Chiba, , Japan
Ichinomiya Nishi Hospital
Ichinomiya, , Japan
Iizuka Hospital
Iizuka, , Japan
Yamanashi Prefectural Central Hospital
Kofu, , Japan
Kokura Memorial Hospital
Kokura, , Japan
Ohtanishinouchi Hospital
Kōriyama, , Japan
Shin-Tokyo Hospital
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Tokyo Metropolitan Hiroo Hospital
Tokyo, , Japan
Tokai University School of Medicine
Tōkai, , Japan
Yamaguchi University Hospital
Ube, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Yokohama Rosai general Hospital
Yokosuka, , Japan
Hospital Universitario de la Ribera
Alzira, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
CHU VIGO
Vigo, , Spain
Basildon University Hospital
Basildon, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Papworth Everard
Cambridge, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Kettering Hospital
Kettering, , United Kingdom
Countries
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References
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Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, Garcia-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.
Other Identifiers
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ISIS ICD - ITSY09
Identifier Type: -
Identifier Source: org_study_id
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