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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Inappropriate Shock(s) | Percentage of patients presenting with inappropriate shock(s) | 552 days |
| Measure | Description | Time Frame |
|---|---|---|
| Shock(s) Appropriately Delivered | Percentage of shocks appropriately delivered | 552 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Cardiovascular Associates | Mesa | Arizona | 85205 | United States | ||
| Pacific Arrhythmia Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30910709 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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ICD device
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| Mesa |
| Arizona |
| 91942 |
| United States |
| Banner Arizona Medical Clinic | Peoria | Arizona | 85381 | United States |
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States |
| Southern California Electrophysiology Associates | Anaheim | California | 92801 | United States |
| Raymond H. M. Schaerf MD, Inc. | Burbank | California | 91505 | United States |
| St. Rose Hospital | Fremont | California | 94538 | United States |
| H. Raj Reddy Md, Inc. | Hanford | California | 93230 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Memorial West Hospital | Pembroke Pines | Florida | 33024 | United States |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | United States |
| University of Chicago | Chicago | Illinois | United States |
| St. Tammany Hospital | Covington | Louisiana | 70433 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Louisiana Heart Center | Slidell | Louisiana | 70458 | United States |
| MGH | Boston | Massachusetts | United States |
| Gulfport Memorial Hospital | Gulfport | Mississippi | 39501 | United States |
| Harlem Cardiology | New York | New York | 10035 | United States |
| Pitt Memeorial Hospital Heart Rhythm Associates | Greenville | North Carolina | 27834 | United States |
| Rex Heart and Vascular Specialists | Raleigh | North Carolina | 27607 | United States |
| Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| The Toledo Hospital | Toledo | Ohio | 43615 | United States |
| Easton Hospital | Easton | Pennsylvania | 18042 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
| Providence Hospital | Columbia | South Carolina | 29204 | United States |
| Carolina Arrhythmia Consultants | Mt. Pleasant | South Carolina | 29464 | United States |
| Centre Hospitalier Universitaire D'Amiens | Amiens | 80090 | France |
| Clinique Saint Joseph | Angers | France |
| Chu Annecy | Annecy | 74011 | France |
| CH Henri Duffaut - Avignon | Avignon | 84902 | France |
| Hôpital Privé de Bois Bernad | Bois-Bernard | 62320 | France |
| CHRU du Morvan Hôpital la Cavale Blanche | Brest | 29069 | France |
| Hôpital Instruction des Armées | Clamart | 92141 | France |
| CH La Rochelle - hôpital St Louis | La Rochelle | 17019 | France |
| CH LENS | Lens | 62307 | France |
| Hopital Saint Joseph et saint Luc | Lyon | France |
| Centre Hospitalier Universitaire de La Timone | Marseille | 13000 | France |
| Hopital Nord | Marseille | France |
| CH Montpellier | Montpellier | France |
| CH Emile Muller | Mulhouse | France |
| CHU Groupe Hospitalo-universitaire Caremeau | Nîmes | 30029 | France |
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Européen Georges Pompidou | Paris | France |
| Centre Hospitalier | Pau | 64000 | France |
| CH Périgueux | Périgueux | 24019 | France |
| CH Yves le Foll | Saint-Brieuc | France |
| Centre Hospitalier de Valence | Valence | 26953 | France |
| CHU Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Klinikum Bogenhausen | Bogenhausen | Germany |
| Universitatsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | 23501 | Germany |
| UKSH Campus Luebeck | Lübeck | 23562 | Germany |
| Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH | Lüneburg | 21339 | Germany |
| Kardiologische Praxis Dr. med Taggeselle | Markkleeberg | Germany |
| DRK Krankenhaus Ratzeburg | Ratzeburg | Germany |
| Policlinico Consorziale di Bari U.O Cardiologia Universitaria | Bari | 70124 | Italy |
| Po Melorio | Santa Maria Capua Vetere | 81055 | Italy |
| Ospedale S.Andrea | Vercelli | 13100 | Italy |
| Chiba University Hospital | Chiba | Japan |
| Ichinomiya Nishi Hospital | Ichinomiya | 494-0001 | Japan |
| Iizuka Hospital | Iizuka | 820-8505 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | 400-8506 | Japan |
| Kokura Memorial Hospital | Kokura | Japan |
| Ohtanishinouchi Hospital | Kōriyama | 963-8558 | Japan |
| Shin-Tokyo Hospital | Tokyo | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo | Japan |
| Tokyo Metropolitan Hiroo Hospital | Tokyo | Japan |
| Tokai University School of Medicine | Tōkai | Japan |
| Yamaguchi University Hospital | Ube | 755-8505 | Japan |
| Yokohama City University Hospital | Yokohama | Japan |
| Yokohama Rosai general Hospital | Yokosuka | 238-8558 | Japan |
| Hospital Universitario de la Ribera | Alzira | 46023 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| CHU VIGO | Vigo | 3204 | Spain |
| Basildon University Hospital | Basildon | England | SS16 | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | FY3 8NR | United Kingdom |
| Papworth Everard | Cambridge | CB23 3RE | United Kingdom |
| Dorset County Hospital | Dorchester | DT1 2JY | United Kingdom |
| Kettering Hospital | Kettering | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The PARAD+ algorithm was enabled in implanted devices in 993 subjects, 639 with an ICD and 354 with a CRT-D, who were thus considered for the primary analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | ICD or CRT-D with PARAD+ |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Inappropriate Shock(s) | Percentage of patients presenting with inappropriate shock(s) | Posted | Number | Percentage of pts with inap shocks | 552 days |
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| Secondary | Shock(s) Appropriately Delivered | Percentage of shocks appropriately delivered | Posted | Number | Percentage of appropriate shocks | 552 days |
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Over a median follow up of 552 days (Q1: 354.0; Q3: 725.0).
Serious adverse events and hospitalizations were documented on specific case report forms and classified by the sponsor's safety officer.
Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 | 70 | 1,013 | 282 | 1,013 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular serious adverse event | Cardiac disorders | Systematic Assessment |
| ||
| Non cardiovascular serious adverse event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Device related serious adverse event | Investigations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Communication manager | LivaNova | 33146013082 | Anne.rousseauplasse@sorin.com |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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