Actively Recruiting
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Led by EBR Systems, Inc. · Updated on 2026-02-06
40
Participants Needed
4
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
CONDITIONS
Official Title
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a class I or IIa indication for CRT device implantation according to guidelines
- Ability to provide written consent or authorization
- Male or female aged 22 years or older
- Meets criteria for one of two patient groups: Group A for new leadless CRT implant or Group B for upgrade from chronic intracardiac pacemaker
- Group A includes patients with symptomatic atrial fibrillation needing AV node ablation or high degree AV block requiring permanent pacing
- Group B includes patients with existing intracardiac pacemakers with over 20% right ventricular pacing and symptomatic heart failure
You will not qualify if you...
- Inability or expected inability to attend follow-up visits
- Female who is pregnant, lactating, or planning pregnancy during the study
- Inability to comply with study follow-up or other requirements
- History of chronic alcohol or drug abuse with current use
- Non-ambulatory or unstable NYHA class 4
- Life expectancy less than 12 months
- Any significant disease or disorder that may increase risk or affect participation or study results
- Enrollment in another clinical study that could confound results (except complementary studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Patients of Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Not Yet Recruiting
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
Not Yet Recruiting
3
Patients of Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Not Yet Recruiting
4
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
C
Christine Phillips
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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