Tachycardia Clinical Trial
— ReduceITOfficial title:
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Verified date | January 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
Status | Completed |
Enrollment | 735 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Ischemic or nonischemic cardiomyopathy - Primary prevention or secondary prevention of Sudden cardiac death (SCD) - Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber) - The patient is = 18 years of age - The patient is able to understand the patient information and is capable to provide informed consent. - The patient has provided written informed consent prior to any investigational related procedure Exclusion Criteria: - Previously implanted ICD/CRT-D - Hypertrophic (with or without obstructive) cardiomyopathy - Ion channel disorders (Long/Short-QT, Brugada syndrome etc…) - New York Heart Association (NYHA) Class IV - Recent cardiac decompensation (within previous 3 months) - The patient is unable to comply with the follow up schedule. - The patient is participating in another investigational device or drug investigation. - The patient is pregnant or is planning to become pregnant during the duration of the investigation |
Country | Name | City | State |
---|---|---|---|
Estonia | North Estonia Medical Centre | Tallinn | |
Estonia | Tartu University Hospital | Tartu | |
Germany | Praxis Dr. med. Bernhardt | Annaberg-Buchholz | |
Germany | Zentralklinik Bad Berka GmbH | Bad Berka | |
Germany | Hufeland Klinikum GmbH | Bad Langensalza | |
Germany | Caritas Krankenhaus | Bad Mergentheim | |
Germany | Medizinisches Versorgungszentrum am Küchwald GmbH | Chemnitz | |
Germany | Praxis Dr. med. Stellmach | Chemnitz | |
Germany | Klinikum Coburg GmbH | Coburg | |
Germany | Klinikum Esslingen | Esslingen | |
Germany | Universitäts-Herzzentrum Freiburg - Bad Krozingen | Freiburg | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Oberhavel Kliniken GmbH Klinik Hennigsdorf | Hennigsdorf | |
Germany | Evangelisches Krankenhaus Holzminden gGmbH | Holzminden | |
Germany | Evangelisches Krankenhaus Kalk gGmbH | Köln | |
Germany | Praxis Frau Dr. med. Gärtner | Leisnig | |
Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | |
Germany | Klinikum Memmingen | Memmingen | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Klinikum Oldenburg gGmbH | Oldenburg | |
Germany | Christliches Krankenhaus Quakenbrück gGmbH | Quakenbrück | |
Germany | Gem.-Praxis Dres. med. Ebert / Stenzel | Riesa | |
Germany | Hegau-Bodensee-Klinikum mbH | Singen |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Estonia, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inappropriate ICD shocks | Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation | 12 months | |
Secondary | ICD shocks for any reason | Freedom from automatically delivered ICD shocks for any reason during FU period | 12 months | |
Secondary | Inappropriate ICD therapies | Freedom from automatically delivered inappropriate ICD therapies during FU period | 12 months | |
Secondary | Untreated VT/VF | Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period | 12 months | |
Secondary | Accuracy of ICD therapy decision | Accuracy of ICD therapy decision (VT/VF and nonVT/VF) | 12 months | |
Secondary | Specificity | Specificity for… … other than sustained VT/VF … SVT (Supraventricular tachycardia) … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT). |
12 months | |
Secondary | Cardiac deaths | Cardiac deaths | 12 months | |
Secondary | Sensitivity | Sensitivity for sustained VT/VF | 12 months | |
Secondary | ICD/CRT-D related SAE | ICD/CRT-D related Serious Adverse Events (SAE) | 12 months |
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