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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1013

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital Pitié-Salpêtrière
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort CRM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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