Randomized trial to study the efficacy and adverse effects of the subcutaneous ICD in patients with a class I or IIa indication for ICD without an indication for pacing

Randomized trial to study the efficacy and adverse effects of the subcutaneous ICD in patients with a class I or IIa indication for ICD without an indication for pacing - Sub-ICD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34509

Enrollment

208

Registered

2011-01-19

Start date

2011-03-03

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

heart rhythm disturbances

Interventions

none

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Class I or IIa indication for ICD

Exclusion criteria

Exclusion criteria: Indication for pacing therapy

Design outcomes

Primary

Measure	Time frame
Number of appropriate shock treatments in ATP or conditional zone in both groups.	—

Secondary

Measure	Time frame
- Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery. - Number of appropriate and inappropriate shocks - Number of complications, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade and lead- or device failures - Quality of life - Time to therapy - First shock conversion efficacy - Implant procedure time - Hospitalization rate (ICD related)	—

Measure

Time frame

- Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery. - Number of appropriate and inappropriate shocks - Number of complications, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade and lead- or device failures - Quality of life - Time to therapy - First shock conversion efficacy - Implant procedure time - Hospitalization rate (ICD related)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)