Tests a leadless heart pacing device in people with heart failure
Tests a wireless heart pacing device, combined with a pacemaker, in adults with heart failure.
Plain-language title generated from the registry record
Registry title: A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Key facts
- Where
- Birtinya, Herston, Southport, and Woolloongabba, AustraliaSee the 4 sites
Where in Australia
- Patients of Sunshine Coast University HospitalBirtinya, AustraliaTaking people
- Royal Brisbane and Women's HospitalHerston, AustraliaTaking people
- Patients of Gold Coast University HospitalSouthport, AustraliaTaking people
- Princess Alexandra HospitalWoolloongabba, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EBR Systems, Inc.
- Trial code
- NCT06561932
- Record updated
- 14 October 2026
- Original description
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.Read full original descriptionShow less
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
Inclusion: Patient with a class I or IIa (1) or (2) indication for implantation of a CRT device according to current available guidelines 1,2,4 (with additional QRS criteria on Class IIa (1)):; Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150 ms; Class IIa (1): NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 130 to < 150 ms; Class IIa (2): NYHA II, III, IV, EF ≤ 35%, non-LBBB, QRS ≥ 150 ms; Patient or legally authorized representative can provide written authorization and/or consent per institution requirements; Male or Female, aged 22 years or above; Meets criteria for one of the two patient groups; Group A: De novo totally leadless CRT implant in whom the physician believes a totally leadless approach would be beneficial (e.g., wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection); Patients with symptomatic AF and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and LVEF), and in whom the physician believes a leadless pacing approach would be beneficial; Patients with high degree AV block who have an indication for permanent pacing (with a LVEF ≤ 50%), are expected to require ventricular pacing more than 40% of the time, and in whom the physician believes a leadless approach would be beneficial; Group B: Upgrade chronic intracardiac pacemaker to CRT; Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.
Exclusion: History of chronic alcohol/ drug abuse and currently using alcohol/ drugs; Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study; Patient who is or is expected to be inaccessible for follow-up visits; Female participant who is pregnant, lactating, or planning pregnancy during the course of the study; Inability to comply with the study follow-up or other study requirements; Non-ambulatory (or unstable) NYHA class 4; Life expectancy less than 12 months; Patient who is enrolled in another clinical study that could confound the results of this study (Note: patients enrolled in complementary study are eligible for enrolment).