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

Primary Purpose

Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia focused on measuring Primary prevention, Secondary prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Southwest Cardiovascular Associates
  • Pacific Arrhythmia Services
  • Banner Arizona Medical Clinic
  • Banner Good Samaritan Medical Center
  • Southern California Electrophysiology Associates
  • Raymond H. M. Schaerf MD, Inc.
  • St. Rose Hospital
  • H. Raj Reddy Md, Inc.
  • Broward General Medical Center
  • Memorial West Hospital
  • Medical Center of Central Georgia
  • University of Chicago
  • St. Tammany Hospital
  • Ochsner Clinic Foundation
  • Louisiana Heart Center
  • MGH
  • Gulfport Memorial Hospital
  • Harlem Cardiology
  • Pitt Memeorial Hospital Heart Rhythm Associates
  • Rex Heart and Vascular Specialists
  • Fairview Hospital
  • The Toledo Hospital
  • Easton Hospital
  • Drexel University College of Medicine
  • Medical University of South Carolina
  • Providence Hospital
  • Carolina Arrhythmia Consultants
  • Centre Hospitalier Universitaire D'Amiens
  • Clinique Saint Joseph
  • Chu Annecy
  • CH Henri Duffaut - Avignon
  • Hôpital Privé de Bois Bernad
  • CHRU du Morvan Hôpital la Cavale Blanche
  • Hôpital Instruction des Armées
  • CH La Rochelle - hôpital St Louis
  • CH LENS
  • Hopital Saint Joseph et saint Luc
  • Centre Hospitalier Universitaire de La Timone
  • Hopital Nord
  • CH Montpellier
  • CH Emile Muller
  • CHU Groupe Hospitalo-universitaire Caremeau
  • Hôpital Pitié-Salpêtrière
  • Hôpital Européen Georges Pompidou
  • Centre Hospitalier
  • CH Périgueux
  • CH Yves le Foll
  • Centre Hospitalier de Valence
  • CHU Brabois
  • Klinikum Bogenhausen
  • UKSH Campus Luebeck
  • Universitatsklinikum Schleswig-Holstein Campus Lübeck
  • Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
  • Kardiologische Praxis Dr. med Taggeselle
  • DRK Krankenhaus Ratzeburg
  • Policlinico Consorziale di Bari U.O Cardiologia Universitaria
  • Po Melorio
  • Ospedale S.Andrea
  • Chiba University Hospital
  • Ichinomiya Nishi Hospital
  • Iizuka Hospital
  • Yamanashi Prefectural Central Hospital
  • Kokura Memorial Hospital
  • Ohtanishinouchi Hospital
  • Tokai University School of Medicine
  • Shin-Tokyo Hospital
  • Tokyo Medical and Dental University Hospital
  • Tokyo Metropolitan Hiroo Hospital
  • Yamaguchi University Hospital
  • Yokohama City University Hospital
  • Yokohama Rosai general Hospital
  • Hospital Universitario de la Ribera
  • Hospital Germans Trias i Pujol
  • Hospital Universitario La Paz
  • CHU VIGO
  • Basildon University Hospital
  • Blackpool Victoria Hospital
  • Papworth Everard
  • Dorset County Hospital
  • Kettering Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ICD or CRT-D with PARAD+

Arm Description

only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator

Outcomes

Primary Outcome Measures

Patients With Inappropriate Shock(s)
Percentage of patients presenting with inappropriate shock(s)

Secondary Outcome Measures

Shock(s) Appropriately Delivered
Percentage of shocks appropriately delivered

Full Information

First Posted
August 3, 2011
Last Updated
March 21, 2019
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT01410552
Brief Title
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Acronym
ISIS-ICD
Official Title
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia
Keywords
Primary prevention, Secondary prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ICD device
Masking
None (Open Label)
Allocation
N/A
Enrollment
1013 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICD or CRT-D with PARAD+
Arm Type
Other
Arm Description
only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator
Intervention Type
Device
Intervention Name(s)
PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
Intervention Description
PARADYM ICD and CRT-d with PARAD+ algorithm available
Primary Outcome Measure Information:
Title
Patients With Inappropriate Shock(s)
Description
Percentage of patients presenting with inappropriate shock(s)
Time Frame
552 days
Secondary Outcome Measure Information:
Title
Shock(s) Appropriately Delivered
Description
Percentage of shocks appropriately delivered
Time Frame
552 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: Any contraindication for ICD therapy Atrial lead not implanted Patient with permanent atrial tachyarrhythmia Patients implanted with a ventricular assist device (VAD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo RUIZ GRANELL, Dr
Organizational Affiliation
Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark RICHARDS, Dr.
Organizational Affiliation
Toledo Hospital, 4614 Brookside Dr. Toledo (OH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Cardiovascular Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85205
Country
United States
Facility Name
Pacific Arrhythmia Services
City
Mesa
State/Province
Arizona
ZIP/Postal Code
91942
Country
United States
Facility Name
Banner Arizona Medical Clinic
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Southern California Electrophysiology Associates
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Raymond H. M. Schaerf MD, Inc.
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
St. Rose Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
H. Raj Reddy Md, Inc.
City
Hanford
State/Province
California
ZIP/Postal Code
93230
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial West Hospital
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
St. Tammany Hospital
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Louisiana Heart Center
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
MGH
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Gulfport Memorial Hospital
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Harlem Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Pitt Memeorial Hospital Heart Rhythm Associates
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Rex Heart and Vascular Specialists
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Easton Hospital
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18042
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Providence Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Carolina Arrhythmia Consultants
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Centre Hospitalier Universitaire D'Amiens
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
Clinique Saint Joseph
City
Angers
Country
France
Facility Name
Chu Annecy
City
Annecy
ZIP/Postal Code
74011
Country
France
Facility Name
CH Henri Duffaut - Avignon
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Hôpital Privé de Bois Bernad
City
Bois Bernard
ZIP/Postal Code
62320
Country
France
Facility Name
CHRU du Morvan Hôpital la Cavale Blanche
City
Brest
ZIP/Postal Code
29069
Country
France
Facility Name
Hôpital Instruction des Armées
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CH La Rochelle - hôpital St Louis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
CH LENS
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
Hopital Saint Joseph et saint Luc
City
Lyon
Country
France
Facility Name
Centre Hospitalier Universitaire de La Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hopital Nord
City
Marseille
Country
France
Facility Name
CH Montpellier
City
Montpellier
Country
France
Facility Name
CH Emile Muller
City
Mulhouse
Country
France
Facility Name
CHU Groupe Hospitalo-universitaire Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Centre Hospitalier
City
PAU
ZIP/Postal Code
64000
Country
France
Facility Name
CH Périgueux
City
Périgueux
ZIP/Postal Code
24019
Country
France
Facility Name
CH Yves le Foll
City
Saint-Brieuc
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Klinikum Bogenhausen
City
Bogenhausen
Country
Germany
Facility Name
UKSH Campus Luebeck
City
Luebeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein Campus Lübeck
City
Lübeck
ZIP/Postal Code
23501
Country
Germany
Facility Name
Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Kardiologische Praxis Dr. med Taggeselle
City
Markkleeberg
Country
Germany
Facility Name
DRK Krankenhaus Ratzeburg
City
Ratzeburg
Country
Germany
Facility Name
Policlinico Consorziale di Bari U.O Cardiologia Universitaria
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Po Melorio
City
Santa Maria Capua Vetere
ZIP/Postal Code
81055
Country
Italy
Facility Name
Ospedale S.Andrea
City
Vercelli
ZIP/Postal Code
13100
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba
Country
Japan
Facility Name
Ichinomiya Nishi Hospital
City
Ichinomiya City
ZIP/Postal Code
494-0001
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka City
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-city
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kokura
Country
Japan
Facility Name
Ohtanishinouchi Hospital
City
Koriyama City
ZIP/Postal Code
963-8558
Country
Japan
Facility Name
Tokai University School of Medicine
City
Tokai
Country
Japan
Facility Name
Shin-Tokyo Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Metropolitan Hiroo Hospital
City
Tokyo
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube City
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
Country
Japan
Facility Name
Yokohama Rosai general Hospital
City
Yokosuka City
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Hospital Universitario de la Ribera
City
Alzira
ZIP/Postal Code
46023
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
CHU VIGO
City
Vigo
ZIP/Postal Code
3204
Country
Spain
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Papworth Everard
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Kettering Hospital
City
Kettering
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30910709
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.
Results Reference
derived

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Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

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