Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
174 participants
OBSERVATIONAL
2013-06-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ICD/CRT-P therapy
Standard indication for ICD or triple-chamber pacemaker therapy
ICD/CRT-P therapy
MRI
Interventions
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ICD/CRT-P therapy
MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Able and willing to complete all testing required by the clinical protocol
* Available for all follow-up visits at the investigational site
* Standard indication for single, dual, or triple chamber ICD or CRT-P.
* ICD or CRT-P system to be implanted in the pectoral region
* Patient body height ≥ 140 cm
* Age ≥ 18 years
Exclusion Criteria
* Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
* Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
* Patient has other metallic artifacts / components in body that may interact with MRI
* Life expectancy of less than eight months
* Cardiac surgery in the next eight months
* Pregnant or breastfeeding
* Enrolled in another non-observational cardiac clinical investigation
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang R. Bauer, Prof.Dr.Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Royal Perth Hospital
Perth, , Australia
Royal North Shore Hospital
Sydney, , Australia
AKH Linz
Linz, , Austria
Landesklinikum St. Pölten
Sankt Pölten, , Austria
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUS - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Royal Alexandra Hospital
Edmonton, , Canada
University Hospital Olomouc
Olomouc, , Czechia
CHU Brest
Brest, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
Schwarzwald Baar Klinikum Villingen Schwenningen
Villingen-Schwenningen, , Germany
Medizinische Universitätsklinik Würzburg
Würzburg, , Germany
Semmelweis University
Budapest, , Hungary
Stadtspital Triemli
Zurich, , Switzerland
Countries
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Other Identifiers
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61
Identifier Type: -
Identifier Source: org_study_id
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