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
Completed
- Conditions
- heart rhythm disturbances1000752110007510
- Registration Number
- NL-OMON34509
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 208
Inclusion Criteria
Class I or IIa indication for ICD
Exclusion Criteria
Indication for pacing therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of appropriate shock treatments in ATP or conditional zone in both<br /><br>groups.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial<br /><br>infarction, percutaneous coronary intervention, coronary artery bypass grafting<br /><br>and/or any valve surgery.<br /><br>- Number of appropriate and inappropriate shocks<br /><br>- Number of complications, defined as infections, bleedings, thrombotic events,<br /><br>pneumothorax, perforation/tamponade and lead- or device failures<br /><br>- Quality of life<br /><br>- Time to therapy<br /><br>- First shock conversion efficacy<br /><br>- Implant procedure time<br /><br>- Hospitalization rate (ICD related)</p><br>