Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:October 2011
End Date:February 2016

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Trial Summary
Trial Overview
Inclusion Criteria
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

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.

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)
We found this trial at
28
sites
Fairview Hospital
Cleveland, Ohio 44111
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Cleveland, OH
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Medical Center of Central Georgia
777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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Macon, GA
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Centre Hospitalier Universitaire D'Amiens
Amiens, 80090
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Amiens,
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Southern California Electrophysiology Associates
Anaheim, California 92801
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Anaheim, CA
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MGH
Boston, Massachusetts 02114
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Boston, MA
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Raymond H. M. Schaerf MD, Inc.
Burbank, California 91505
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Burbank, CA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Providence Hospital
Columbia, South Carolina 29204
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Columbia, SC
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St. Tammany Hospital
Covington, Louisiana 70433
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Covington, LA
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Easton Hospital
Easton, Pennsylvania 18042
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Easton, PA
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Broward General Medical Center
Fort Lauderdale, Florida 33316
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from
Fort Lauderdale, FL
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St. Rose Hospital
Fremont, California 94538
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from
Fremont, CA
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Pitt Memeorial Hospital Heart Rhythm Associates
Greenville, North Carolina 27834
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from
Greenville, NC
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Gulfport Memorial Hospital
Gulfport, Mississippi 39502
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from
Gulfport, MS
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H. Raj Reddy Md, Inc.
Hanford, California 93230
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from
Hanford, CA
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Southwest Cardiovascular Associates
Mesa, Arizona 85205
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Mesa, AZ
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Pacific Arrhythmia Services
Mesa, Arizona 91942
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Mesa, AZ
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Carolina Arrhythmia Consultants
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Ochsner Clinic Foundation
New Orleans, Louisiana 70121
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New Orleans, LA
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Harlem Cardiology
1787 Madison Avenue
New York, New York 10035
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New York, NY
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Memorial West Hospital
Pembroke Pines, Florida 33024
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Pembroke Pines, FL
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Banner Arizona Medical Clinic
Peoria, Arizona 85381
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Peoria, AZ
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Drexel University College of Medicine
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, PA
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Banner Good Samaritan Medical Center
Phoenix, Arizona 85006
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Phoenix, AZ
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Rex Heart and Vascular Specialists
Raleigh, North Carolina 27607
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Raleigh, NC
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Louisiana Heart Center
Slidell, Louisiana 70458
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Slidell, LA
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Toledo Hospital
2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Toledo, OH
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