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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009223
Enrollment
500
Registered
2015-08-12
Start date
2012-10-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I42.0 I25.5 Z45.01

Interventions

Group 1: Patients without DFT during ICD aggregate change, ie no implementation according indication grantor or operating cardiologist or cardiac surgeon or patients with iatrogenic not inducible vent

Sponsors

Universitätklinik für Kardiologie, Angiologie und Pneumologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Prevalence, incidence and prediction factors for ineffective intraoperative DFT during performed ICD generator change

Secondary

MeasureTime frame
Safety and tolerability of conducted DFT during ICD generator change, ICD-related complications, compared shock effectiveness and patient mortality

Countries

Germany

Contacts

Public ContactThomas Rauwolf

Universitätsklinik für Kardiologie, Angiologie und Pneumologie

kkar@med.ovgu.de+49-391-67-13207

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026