Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

NCT01410552 | Completed Results

• 1 other identifier: ISIS ICD - ITSY09
• Study Type: interventional
• Target: 1,013
• Locations: 7 countries
• Sites: 80

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

Conditions

Tachycardia

Keywords

Primary prevention; Secondary prevention

Outcome Measures

Primary Outcomes (1)

• Patients With Inappropriate Shock(s)

  Percentage of patients presenting with inappropriate shock(s)

  552 days

Secondary Outcomes (1)

• Shock(s) Appropriately Delivered

  552 days

Study Arms (1)

ICD or CRT-D with PARAD+

OTHER

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

Interventions

PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770 DEVICE

PARADYM ICD and CRT-d with PARAD+ algorithm available

ICD or CRT-D with PARAD+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any contraindication for ICD therapy
• Atrial lead not implanted
• Patient with permanent atrial tachyarrhythmia
• Patients implanted with a ventricular assist device (VAD)

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (80)

Southwest Cardiovascular Associates

Mesa, Arizona, 85205, United States

Location

Pacific Arrhythmia Services

Mesa, Arizona, 91942, United States

Location

Banner Arizona Medical Clinic

Peoria, Arizona, 85381, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Southern California Electrophysiology Associates

Anaheim, California, 92801, United States

Location

Raymond H. M. Schaerf MD, Inc.

Burbank, California, 91505, United States

Location

St. Rose Hospital

Fremont, California, 94538, United States

Location

H. Raj Reddy Md, Inc.

Hanford, California, 93230, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial West Hospital

Pembroke Pines, Florida, 33024, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

St. Tammany Hospital

Covington, Louisiana, 70433, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana Heart Center

Slidell, Louisiana, 70458, United States

Location

MGH

Boston, Massachusetts, United States

Location

Gulfport Memorial Hospital

Gulfport, Mississippi, 39501, United States

Location

Harlem Cardiology

New York, New York, 10035, United States

Location

Pitt Memeorial Hospital Heart Rhythm Associates

Greenville, North Carolina, 27834, United States

Location

Rex Heart and Vascular Specialists

Raleigh, North Carolina, 27607, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

The Toledo Hospital

Toledo, Ohio, 43615, United States

Location

Easton Hospital

Easton, Pennsylvania, 18042, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Providence Hospital

Columbia, South Carolina, 29204, United States

Location

Carolina Arrhythmia Consultants

Mt. Pleasant, South Carolina, 29464, United States

Location

Centre Hospitalier Universitaire D'Amiens

Amiens, 80090, France

Location

Clinique Saint Joseph

Angers, France

Location

Chu Annecy

Annecy, 74011, France

Location

CH Henri Duffaut - Avignon

Avignon, 84902, France

Location

Hôpital Privé de Bois Bernad

Bois-Bernard, 62320, France

Location

CHRU du Morvan Hôpital la Cavale Blanche

Brest, 29069, France

Location

Hôpital Instruction des Armées

Clamart, 92141, France

Location

CH La Rochelle - hôpital St Louis

La Rochelle, 17019, France

Location

CH LENS

Lens, 62307, France

Location

Hopital Saint Joseph et saint Luc

Lyon, France

Location

Centre Hospitalier Universitaire de La Timone

Marseille, 13000, France

Location

Hopital Nord

Marseille, France

Location

CH Montpellier

Montpellier, France

Location

CH Emile Muller

Mulhouse, France

Location

CHU Groupe Hospitalo-universitaire Caremeau

Nîmes, 30029, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Centre Hospitalier

Pau, 64000, France

Location

CH Périgueux

Périgueux, 24019, France

Location

CH Yves le Foll

Saint-Brieuc, France

Location

Centre Hospitalier de Valence

Valence, 26953, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Klinikum Bogenhausen

Bogenhausen, Germany

Location

Universitatsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23501, Germany

Location

UKSH Campus Luebeck

Lübeck, 23562, Germany

Location

Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH

Lüneburg, 21339, Germany

Location

Kardiologische Praxis Dr. med Taggeselle

Markkleeberg, Germany

Location

DRK Krankenhaus Ratzeburg

Ratzeburg, Germany

Location

Policlinico Consorziale di Bari U.O Cardiologia Universitaria

Bari, 70124, Italy

Location

Po Melorio

Santa Maria Capua Vetere, 81055, Italy

Location

Ospedale S.Andrea

Vercelli, 13100, Italy

Location

Chiba University Hospital

Chiba, Japan

Location

Ichinomiya Nishi Hospital

Ichinomiya, 494-0001, Japan

Location

Iizuka Hospital

Iizuka, 820-8505, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

Location

Kokura Memorial Hospital

Kokura, Japan

Location

Ohtanishinouchi Hospital

Kōriyama, 963-8558, Japan

Location

Shin-Tokyo Hospital

Tokyo, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, Japan

Location

Tokyo Metropolitan Hiroo Hospital

Tokyo, Japan

Location

Tokai University School of Medicine

Tōkai, Japan

Location

Yamaguchi University Hospital

Ube, 755-8505, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

Yokohama Rosai general Hospital

Yokosuka, 238-8558, Japan

Location

Hospital Universitario de la Ribera

Alzira, 46023, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

CHU VIGO

Vigo, 3204, Spain

Location

Basildon University Hospital

Basildon, England, SS16, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, FY3 8NR, United Kingdom

Location

Papworth Everard

Cambridge, CB23 3RE, United Kingdom

Location

Dorset County Hospital

Dorchester, DT1 2JY, United Kingdom

Location

Kettering Hospital

Kettering, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30910709 DERIVED

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Scientific Communication manager
• Organization: LivaNova

Anne.rousseauplasse@sorin.com

33146013082

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ICD device

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 5, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 22, 2019
• Results First Posted: February 12, 2018

Record last verified: 2019-03

Locations

ES (4); IT (3); GB (5); DE (6); JP (13); US (27); FR (22)