Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination (ISIS-ICD)

March 21, 2019 updated by: MicroPort CRM
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80090
        • Centre Hospitalier Universitaire d'Amiens
      • Angers, France
        • Clinique Saint Joseph
      • Annecy, France, 74011
        • CHU Annecy
      • Avignon, France, 84902
        • CH Henri Duffaut - Avignon
      • Bois Bernard, France, 62320
        • Hôpital Privé de Bois Bernad
      • Brest, France, 29069
        • CHRU du Morvan Hôpital la Cavale Blanche
      • Clamart, France, 92141
        • Hopital Instruction Des Armees
      • La Rochelle, France, 17019
        • CH La Rochelle - hôpital St Louis
      • Lens, France, 62307
        • CH LENS
      • Lyon, France
        • Hopital Saint Joseph et saint Luc
      • Marseille, France, 13000
        • Centre Hospitalier Universitaire de La Timone
      • Marseille, France
        • Hopital Nord
      • Montpellier, France
        • CH Montpellier
      • Mulhouse, France
        • CH Emile Muller
      • Nimes, France, 30029
        • CHU Groupe Hospitalo-universitaire Caremeau
      • PAU, France, 64000
        • Centre hospitalier
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Périgueux, France, 24019
        • CH Périgueux
      • Saint-Brieuc, France
        • CH Yves Le Foll
      • Valence, France, 26953
        • Centre Hospitalier de Valence
      • Vandoeuvre Les Nancy, France, 54500
        • Chu Brabois
  • Germany
      • Bogenhausen, Germany
        • Klinikum Bogenhausen
      • Luebeck, Germany, 23562
        • UKSH Campus Luebeck
      • Lübeck, Germany, 23501
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • Lüneburg, Germany, 21339
        • Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
      • Markkleeberg, Germany
        • Kardiologische Praxis Dr. med Taggeselle
      • Ratzeburg, Germany
        • DRK Krankenhaus Ratzeburg
  • Italy
      • Bari, Italy, 70124
        • Policlinico Consorziale di Bari U.O Cardiologia Universitaria
      • Santa Maria Capua Vetere, Italy, 81055
        • Po Melorio
      • Vercelli, Italy, 13100
        • Ospedale S.Andrea
  • Japan
      • Chiba, Japan
        • Chiba University Hospital
      • Ichinomiya City, Japan, 494-0001
        • Ichinomiya Nishi Hospital
      • Iizuka City, Japan, 820-8505
        • Iizuka Hospital
      • Kofu-city, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Kokura, Japan
        • Kokura Memorial Hospital
      • Koriyama City, Japan, 963-8558
        • Ohtanishinouchi Hospital
      • Tokai, Japan
        • Tokai University School of Medicine
      • Tokyo, Japan
        • Shin-Tokyo Hospital
      • Tokyo, Japan
        • Tokyo Medical and Dental University Hospital
      • Tokyo, Japan
        • Tokyo Metropolitan Hiroo Hospital
      • Ube City, Japan, 755-8505
        • Yamaguchi University Hospital
      • Yokohama, Japan
        • Yokohama City University Hospital
      • Yokosuka City, Japan, 238-8558
        • Yokohama Rosai general Hospital
  • Spain
      • Alzira, Spain, 46023
        • Hospital Universitario de La Ribera
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Vigo, Spain, 3204
        • CHU VIGO
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Everard
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Kettering, United Kingdom
        • Kettering Hospital
    • England
      • Basildon, England, United Kingdom, SS16
        • Basildon University Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Southwest Cardiovascular Associates
      • Mesa, Arizona, United States, 91942
        • Pacific Arrhythmia Services
      • Peoria, Arizona, United States, 85381
        • Banner Arizona Medical Clinic
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • California
      • Anaheim, California, United States, 92801
        • Southern California Electrophysiology Associates
      • Burbank, California, United States, 91505
        • Raymond H. M. Schaerf MD, Inc.
      • Fremont, California, United States, 94538
        • St. Rose Hospital
      • Hanford, California, United States, 93230
        • H. Raj Reddy Md, Inc.
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Pembroke Pines, Florida, United States, 33024
        • Memorial West Hospital
    • Georgia
      • Macon, Georgia, United States, 31201
        • Medical Center of Central Georgia
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • St. Tammany Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Slidell, Louisiana, United States, 70458
        • Louisiana Heart Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • MGH
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Gulfport Memorial Hospital
    • New York
      • New York, New York, United States, 10035
        • Harlem Cardiology
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Pitt Memeorial Hospital Heart Rhythm Associates
      • Raleigh, North Carolina, United States, 27607
        • Rex Heart and Vascular Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital
      • Toledo, Ohio, United States, 43615
        • The Toledo Hospital
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18042
        • Easton Hospital
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29204
        • Providence Hospital
      • Mount Pleasant, South Carolina, United States, 29464
        • Carolina Arrhythmia Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Inappropriate Shock(s)
Time Frame: 552 days
Percentage of patients presenting with inappropriate shock(s)
552 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shock(s) Appropriately Delivered
Time Frame: 552 days
Percentage of shocks appropriately delivered
552 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS ICD - ITSY09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tachycardia

Clinical Trials on PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770

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