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MiniImal Defibrillation Threshold in With a Subcutaneous Implantable-Defibrillator Patients Undergoing Elective Generator Replacement.

MiniImal Defibrillation Threshold in With a Subcutaneous Implantable-Defibrillator Patients Undergoing Elective Generator Replacement. - MINI Two Study

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48785
Enrollment
45
Registered
2018-08-15
Start date
2018-09-10
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Abnormal heart rhythm ventricular arrhythmias

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients can be included if they: - are over 18 - are able to give informed consent - will undergo S-ICD generator replacement and subsequent defibrillation threshold testing (DFT)

Exclusion criteria

Exclusion criteria: Patients who will not undergo defibrillation testing as part of their regular care due toa contra-indication. Patients with a BMI

Design outcomes

Primary

MeasureTime frame
Outcome The main outcome will be the lowest energy on which defibrillation of the induced ventricular arrhythmia was successful after replacement of the S-ICD generator.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)