Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
160

Inclusion Criteria

Legal capacity and ability to consent.
Patient is willing and able to activate and use the CardioMessenger
Standard indication for an ICD/CRT-D therapy
...
Legal capacity and ability to consent.
Patient is willing and able to activate and use the CardioMessenger
Standard indication for an ICD/CRT-D therapy
Patient is willing and able to participate for the whole study duration
Signed informed consent form

Exclusion Criteria

Pregnant or breastfeeding
Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
Cardiac surgery is planned within the next six months
...
Pregnant or breastfeeding
Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
Cardiac surgery is planned within the next six months
Dexamethasone acetate intolerance
Age <18 years.
Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
Enrollment in another cardiac clinical investigation with active treatment arm
Standard contraindication for an ICD/CRT-D therapy

Summary

Conditions
  • Heart Failure
  • Ventricular Fibrillation
  • Ventricular Tachycardia
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Legal capacity and ability to consent.
Patient is willing and able to activate and use the CardioMessenger
Standard indication for an ICD/CRT-D therapy
...
Legal capacity and ability to consent.
Patient is willing and able to activate and use the CardioMessenger
Standard indication for an ICD/CRT-D therapy
Patient is willing and able to participate for the whole study duration
Signed informed consent form

Exclusion Criteria

Pregnant or breastfeeding
Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
Cardiac surgery is planned within the next six months
...
Pregnant or breastfeeding
Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
Cardiac surgery is planned within the next six months
Dexamethasone acetate intolerance
Age <18 years.
Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
Enrollment in another cardiac clinical investigation with active treatment arm
Standard contraindication for an ICD/CRT-D therapy

Tracking Information

NCT #
NCT01836497
Collaborators
Not Provided
Investigators
  • Principal Investigator: Roland Richard Tilz, Prof. Dr. med. University Clinic of Schleswig-Holstein, Lübeck, Germany
  • Roland Richard Tilz, Prof. Dr. med. University Clinic of Schleswig-Holstein, Lübeck, Germany
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