Tachycardia Clinical Trial
— ISIS-ICDOfficial title:
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
| Verified date | March 2019 |
| Source | MicroPort CRM |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1013 |
| Est. completion date | February 2016 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire D'Amiens | Amiens | |
| France | Clinique Saint Joseph | Angers | |
| France | Chu Annecy | Annecy | |
| France | CH Henri Duffaut - Avignon | Avignon | |
| France | Hôpital Privé de Bois Bernad | Bois Bernard | |
| France | CHRU du Morvan Hôpital la Cavale Blanche | Brest | |
| France | Hôpital Instruction des Armées | Clamart | |
| France | CH La Rochelle - hôpital St Louis | La Rochelle | |
| France | CH LENS | Lens | |
| France | Hopital Saint Joseph et saint Luc | Lyon | |
| France | Centre Hospitalier Universitaire de La Timone | Marseille | |
| France | Hopital Nord | Marseille | |
| France | CH Montpellier | Montpellier | |
| France | CH Emile Muller | Mulhouse | |
| France | CHU Groupe Hospitalo-universitaire Caremeau | Nimes | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hôpital Pitié-Salpêtrière | Paris | |
| France | Centre Hospitalier | PAU | |
| France | CH Périgueux | Périgueux | |
| France | CH Yves le Foll | Saint-Brieuc | |
| France | Centre Hospitalier de Valence | Valence | |
| France | CHU Brabois | Vandoeuvre Les Nancy | |
| Germany | Klinikum Bogenhausen | Bogenhausen | |
| Germany | Universitatsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | |
| Germany | UKSH Campus Luebeck | Luebeck | |
| Germany | Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH | Lüneburg | |
| Germany | Kardiologische Praxis Dr. med Taggeselle | Markkleeberg | |
| Germany | DRK Krankenhaus Ratzeburg | Ratzeburg | |
| Italy | Policlinico Consorziale di Bari U.O Cardiologia Universitaria | Bari | |
| Italy | Po Melorio | Santa Maria Capua Vetere | |
| Italy | Ospedale S.Andrea | Vercelli | |
| Japan | Chiba University Hospital | Chiba | |
| Japan | Ichinomiya Nishi Hospital | Ichinomiya City | |
| Japan | Iizuka Hospital | Iizuka City | |
| Japan | Yamanashi Prefectural Central Hospital | Kofu-city | |
| Japan | Kokura Memorial Hospital | Kokura | |
| Japan | Ohtanishinouchi Hospital | Koriyama City | |
| Japan | Tokai University School of Medicine | Tokai | |
| Japan | Shin-Tokyo Hospital | Tokyo | |
| Japan | Tokyo Medical and Dental University Hospital | Tokyo | |
| Japan | Tokyo Metropolitan Hiroo Hospital | Tokyo | |
| Japan | Yamaguchi University Hospital | Ube City | |
| Japan | Yokohama City University Hospital | Yokohama | |
| Japan | Yokohama Rosai general Hospital | Yokosuka City | |
| Spain | Hospital Universitario de la Ribera | Alzira | |
| Spain | Hospital Germans Trias i Pujol | Badalona | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | CHU VIGO | Vigo | |
| United Kingdom | Basildon University Hospital | Basildon | England |
| United Kingdom | Blackpool Victoria Hospital | Blackpool | |
| United Kingdom | Papworth Everard | Cambridge | |
| United Kingdom | Dorset County Hospital | Dorchester | |
| United Kingdom | Kettering Hospital | Kettering | |
| United States | Southern California Electrophysiology Associates | Anaheim | California |
| United States | MGH | Boston | Massachusetts |
| United States | Raymond H. M. Schaerf MD, Inc. | Burbank | California |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Chicago | Chicago | Illinois |
| United States | Fairview Hospital | Cleveland | Ohio |
| United States | Providence Hospital | Columbia | South Carolina |
| United States | St. Tammany Hospital | Covington | Louisiana |
| United States | Easton Hospital | Easton | Pennsylvania |
| United States | Broward General Medical Center | Fort Lauderdale | Florida |
| United States | St. Rose Hospital | Fremont | California |
| United States | Pitt Memeorial Hospital Heart Rhythm Associates | Greenville | North Carolina |
| United States | Gulfport Memorial Hospital | Gulfport | Mississippi |
| United States | H. Raj Reddy Md, Inc. | Hanford | California |
| United States | Medical Center of Central Georgia | Macon | Georgia |
| United States | Pacific Arrhythmia Services | Mesa | Arizona |
| United States | Southwest Cardiovascular Associates | Mesa | Arizona |
| United States | Carolina Arrhythmia Consultants | Mount Pleasant | South Carolina |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Harlem Cardiology | New York | New York |
| United States | Memorial West Hospital | Pembroke Pines | Florida |
| United States | Banner Arizona Medical Clinic | Peoria | Arizona |
| United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
| United States | Banner Good Samaritan Medical Center | Phoenix | Arizona |
| United States | Rex Heart and Vascular Specialists | Raleigh | North Carolina |
| United States | Louisiana Heart Center | Slidell | Louisiana |
| United States | The Toledo Hospital | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| MicroPort CRM |
United States, France, Germany, Italy, Japan, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients With Inappropriate Shock(s) | Percentage of patients presenting with inappropriate shock(s) | 552 days | |
| Secondary | Shock(s) Appropriately Delivered | Percentage of shocks appropriately delivered | 552 days |
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