A Prospective Randomised CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation Testing

Recruiting

• Conditions: heart rhythm disturbances; 10007521; 10007510

• Registration Number: NL-OMON54525
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 305

Inclusion Criteria

• Patients must be >= 18 years of age, willing and capable of giving informed
consent
• Patients who meet current guidelines for ICD therapy and intend to undergo a
de novo implant procedure for an S-ICD.
• Patients must pass S-ICD screening per local routine
• Patients willing and capable of complying with follow-up visits
• Patients must be eligible for both DFT strategies per physician discretion.

Exclusion Criteria

• Patients with life expectancy shorter than 12 months due to any medical
condition
• Patients who are known to be pregnant
• Patients with intracardiac thrombus
• Patients with atrial fibrillation without appropriate anticoagulation
• Patients likely to undergo heart transplant within 12 months
• Patients with LVAD
• Patients with a BMI > 40
• Patients with other contra-indications for DFT per physician*s discretion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of this study is the first shock efficacy in spontaneous<br /><br>events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include DFT related complications, PRAETORIAN Score (chest<br /><br>X-ray implant score), pain score at baseline and after implant, Mortality<br /><br>(all-cause, arrhythmic death, cardiovascular death, unexplained death), Device<br /><br>or lead repositioning, MACE within 30 days post-implant, successful shock (in<br /><br>both DFT and spontaneous events), time to (successful) therapy, inappropriate<br /><br>therapy, cardiac (pre-)syncope, cardiac decompensation, length of<br /><br>hospitalization post implant and ICD related infection. </p><br>