Pacing Alternate Sites using SelectSecure (PASSES Study): To assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead.

Category Primary study
Registry of TrialsANZCTR
Year 2008
INTERVENTION: Implantation of a dual chamber pacemaker and leads (catheter delivered or stylet) at alternate pacing site (Right Ventricular Outflow Tract (RVOT) and Right Atrial septum). This is a permanent pacemaker implant involving a one‐off surgical procedure. CONDITION: Dual Chamber pacemakers PRIMARY OUTCOME: Implant success rate measured with Fluoroscopy images, 12 lead paced Echocardiogram (ECG) and Physician assessment for position verification. SECONDARY OUTCOME: Atrial Fibrillation and Heart failure burden measured by Physician assessment of Heart Failure (New York Heart Association Classification) and Pacemaker diagnostics for Atrial Fibrillation burden . Health Care Utilisation collected from medical records and a Patient Diary. Patient Symptoms (questions asked to patients by Physician at follow‐up visits), and Adverse events. Eg. Implant complications, lead performance outside expectation such as dislodgement, loss of capture, threshols and sendsing concerns. These will be collected at follow up visits by testing the electrical performance of the leads and reviewing the device diagnostics. INCLUSION CRITERIA: Patient has standard indications for first implantation of a dual chamber Brady Pacemaker
Epistemonikos ID: 0e99f64c4ec6b2d3b6f046f45644e0861a0c5e98
First added on: Aug 25, 2024