Clinical trial NCT01410552: Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Official title: Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia
Keywords: Primary prevention
Secondary prevention
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ICD device
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
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:

1. Any contraindication for ICD therapy
2. Atrial lead not implanted
3. Patient with permanent atrial tachyarrhythmia
4. Patients implanted with a ventricular assist device (VAD)

Primary outcomes:
measure: Patients With Inappropriate Shock(s)
timeFrame: 552 days
Secondary outcomes:
measure: Shock(s) Appropriately Delivered
timeFrame: 552 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Mesa
country: United States
facility: Pacific Arrhythmia Services
state: Arizona
city: Peoria
country: United States
facility: Banner Arizona Medical Clinic
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Anaheim
country: United States
facility: Southern California Electrophysiology Associates
state: California
city: Burbank
country: United States
facility: Raymond H. M. Schaerf MD, Inc.
state: California
city: Fremont
country: United States
facility: St. Rose Hospital
state: California
city: Hanford
country: United States
facility: H. Raj Reddy Md, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial West Hospital
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Covington
country: United States
facility: St. Tammany Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Slidell
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Boston
country: United States
facility: MGH
state: Massachusetts
city: Gulfport
country: United States
facility: Gulfport Memorial Hospital
state: Mississippi
city: New York
country: United States
facility: Harlem Cardiology
state: New York
city: Greenville
country: United States
facility: Pitt Memeorial Hospital Heart Rhythm Associates
state: North Carolina
city: Raleigh
country: United States
facility: Rex Heart and Vascular Specialists
state: North Carolina
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Easton
country: United States
facility: Easton Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Providence Hospital
state: South Carolina
city: Mount Pleasant
country: United States
facility: Carolina Arrhythmia Consultants
state: South Carolina
city: Amiens
country: France
facility: Centre Hospitalier Universitaire D'Amiens
city: Angers
country: France
facility: Clinique Saint Joseph
city: Annecy
country: France
facility: Chu Annecy
city: Avignon
country: France
facility: CH Henri Duffaut - Avignon
city: Bois Bernard
country: France
facility: Hôpital Privé de Bois Bernad
city: Brest
country: France
facility: CHRU du Morvan Hôpital la Cavale Blanche
city: Clamart
country: France
facility: Hôpital Instruction des Armées
city: La Rochelle
country: France
facility: CH La Rochelle - hôpital St Louis
city: Lens
country: France
facility: CH LENS
city: Lyon
country: France
facility: Hopital Saint Joseph et saint Luc
city: Marseille
country: France
facility: Centre Hospitalier Universitaire de La Timone
city: Marseille
country: France
facility: Hopital Nord
city: Montpellier
country: France
facility: CH Montpellier
city: Mulhouse
country: France
facility: CH Emile Muller
city: Nimes
country: France
facility: CHU Groupe Hospitalo-universitaire Caremeau
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: PAU
country: France
facility: Centre Hospitalier
city: Périgueux
country: France
facility: CH Périgueux
city: Saint-Brieuc
country: France
facility: CH Yves le Foll
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Vandoeuvre Les Nancy
country: France
facility: CHU Brabois
city: Bogenhausen
country: Germany
facility: Klinikum Bogenhausen
city: Luebeck
country: Germany
facility: UKSH Campus Luebeck
city: Lübeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck
city: Lüneburg
country: Germany
facility: Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
city: Markkleeberg
country: Germany
facility: Kardiologische Praxis Dr. med Taggeselle
city: Ratzeburg
country: Germany
facility: DRK Krankenhaus Ratzeburg
city: Bari
country: Italy
facility: Policlinico Consorziale di Bari U.O Cardiologia Universitaria
city: Santa Maria Capua Vetere
country: Italy
facility: Po Melorio
city: Vercelli
country: Italy
facility: Ospedale S.Andrea
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Ichinomiya City
country: Japan
facility: Ichinomiya Nishi Hospital
city: Iizuka City
country: Japan
facility: Iizuka Hospital
city: Kofu-city
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kokura
country: Japan
facility: Kokura Memorial Hospital
city: Koriyama City
country: Japan
facility: Ohtanishinouchi Hospital
city: Tokai
country: Japan
facility: Tokai University School of Medicine
city: Tokyo
country: Japan
facility: Shin-Tokyo Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital
city: Ube City
country: Japan
facility: Yamaguchi University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yokosuka City
country: Japan
facility: Yokohama Rosai general Hospital
city: Alzira
country: Spain
facility: Hospital Universitario de la Ribera
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Vigo
country: Spain
facility: CHU VIGO
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Everard
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Kettering
country: United Kingdom
facility: Kettering Hospital
Study officials:
affiliation: Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
name: Ricardo RUIZ GRANELL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Toledo Hospital, 4614 Brookside Dr. Toledo (OH)
name: Mark RICHARDS, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.