Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing. Single-arm, prospective, multicenter, observational study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.
Patients of Sunshine Coast University Hospital
Birtinya, Queensland, Australia
NOT_YET_RECRUITINGRoyal Brisbane and Women's Hospital
Herston, Queensland, Australia
NOT_YET_RECRUITINGPatients of Gold Coast University Hospital
Southport, Queensland, Australia
NOT_YET_RECRUITINGIncidence of Device and procedure related complications.
Primary Safety
Time frame: 1 month and 6 months
Bi-Ventricular capture on 12 lead EKG
Performance
Time frame: 1 month and 6 months
Change in ejection fraction (EF) from Baseline
Secondary efficacy 1
Time frame: 6 months
Change in in left ventricular end systolic volume (LVESV)
Secondary efficacy 2
Time frame: 6 months
Change in NYHA class
Secondary efficacy 3
Time frame: 6 months
Change in Six-minute walk test
Secondary efficacy 4
Time frame: 6 months
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Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
RECRUITING