Testing of defibrillation during aggregate change of ICD -additional safety and efficacy benefits or already obsolete?

• Conditions: I42.0; I25.5; Z45.01; Dilated cardiomyopathy; Ischaemic cardiomyopathy

• Registration Number: DRKS00009223
• Lead Sponsor: niversitätklinik für Kardiologie, Angiologie und Pneumologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-07-01
• Study Start: 2015-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Male, Female
2. age: min. 18 years, max. 90 years
3. Patients with ICD generator change

Exclusion Criteria

1. Lack of consent / awareness for surgical indications, surgical procedure and - complications and with respect to the Defibrillationstestung at an ICD generator change
2. Rejection of use of defibrillation by a patient
3. Lack of legal protection for underage patients
4. Contraindications to ICD generator replacement: poor general condition and such serious diseases, which do not allow such an intervention
5. Contraindications for intraoperative DFT such as intracardiac thrombi, pericardial effusion, pneumothorax, acute coronary syndrome, stroke
6. pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence, incidence and prediction factors for ineffective intraoperative DFT during performed ICD generator change

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of conducted DFT during ICD generator change, ICD-related complications, compared shock effectiveness and patient mortality