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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of co-implanting the WiSE CRT System with an intracardiac pacemaker to achieve a completely leadless cardiac resynchronization therapy (CRT) for patients with heart failure. This single-arm, prospective, multicenter observational study focuses on delivering biventricular pacing by combining left ventricular pacing from the WiSE CRT System with right ventricular stimulation from a co-implanted device. The study aims to understand how well this leadless approach works and its related risks. Participants will receive the WiSE CRT System implanted to provide left ventricular pacing along with an intracardiac pacemaker for right ventricular pacing, together delivering biventricular stimulation. This therapy is given alongside guideline-directed medical therapy. The study observes participants over time without comparing to a control group. During the study, participants will be monitored for device- and procedure-related complications and for evidence of biventricular capture on electrocardiograms at one month and six months after implantation. Researchers will also assess changes in heart function, including ejection fraction, left ventricular end systolic volume, heart failure symptom class, and walking ability at six months. The study includes follow-up visits to evaluate safety and heart performance, with participation lasting at least six months.
CONDITIONS
Brief 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
- Male or female aged 22 years or older
- Ability to provide written consent
- Meets criteria for either de novo totally leadless CRT implant or upgrade from existing pacemaker with symptomatic heart failure
- Includes patients with symptomatic atrial fibrillation needing AV node ablation or high degree AV block requiring permanent pacing with LVEF ≤ 50%
You will not qualify if you...
- Inability or expected inability to attend follow-up visits
- Pregnant, lactating, or planning pregnancy during study
- Inability to comply with study follow-up or requirements
- History of chronic alcohol or drug abuse with current use
- Non-ambulatory or unstable NYHA class IV heart failure
- Life expectancy less than 12 months
- Any other disease or disorder that may increase risk or affect study participation
- Enrollment in another clinical trial that could confound results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants receive the implant of the WiSE CRT System along with an intracardiac pacemaker to achieve totally leadless cardiac resynchronization therapy.
1 implant procedure visit
Duration - 6 months
Participants are treated with the WiSE CRT System combined with guideline-directed medical therapy to provide biventricular pacing.
Visits at 1 month and 6 months post-implant
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
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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