Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
160

Inclusion Criteria

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

Exclusion Criteria

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

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

Exclusion Criteria

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

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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