A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

ID#: NCT03495297

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 07, 2018

End Date: September 01, 2023

Contact Information:
Reinoud E Knops, MD, PhD
+31205666555
Lonneke Schats - Smeding, PhD
+31205665424
Summary: This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.
Eligibility:

Inclusion Criteria:

- Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD

- Patients must pass S-ICD screening per local routine

- Patients over 18 years of age, willing and capable to give informed consent

- Patients must be willing and capable of complying to follow up visits

- Patient must be eligible for either DFT strategy per physician discretion

Exclusion Criteria:

- Patient with a life expectancy shorter than 12 months due to any medical condition

- Patients 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 other contra-indications for DFT per physician's discretion
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