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.
Phase 4
Active, not recruiting
- Conditions
- Dual Chamber pacemakersCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12608000593336
- Lead Sponsor
- Medtronic Australasia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Patient has standard indications for first implantation of a dual chamber Brady Pacemaker
Exclusion Criteria
Previous pacemaker implant and
patients with mechanical right heart valves
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant success rate measured with Fluoroscopy images, 12 lead paced Echocardiogram (ECG) and Physician assessment for position verification.[Implant, Pre-hospital discharge, 3 months]
- Secondary Outcome Measures
Name Time Method Health Care Utilisation collected from medical records and a Patient Diary.[Pre-hospital Discharge (PHD), 3 months, 6 months, 6 monthly for up to 10 years];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 .[PHD, 3 months, 6 months, 6 monthly for up to 10 years];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.[PHD, 3 months, 6 months, 6 monthly for up to 10 years]