Totally leadless cardiac resynchronization using the WiSE CRT system with an intracardiac pacemaker

A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

This study will test whether implanting the WiSE CRT system together with an intracardiac pacemaker can provide totally leadless cardiac resynchronization therapy for people with heart failure who qualify for CRT.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: EBR Systems, Inc. (industry)
• Locations: 4 sites (Birtinya, Queensland and 3 other locations)
• Trial ID: NCT06561932 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective, multicenter observational study enrolling patients who meet guideline indications for CRT and in whom a totally leadless approach is considered beneficial. Participants receive the WiSE CRT System for left ventricular pacing alongside a co-implanted intracardiac device that provides right ventricular stimulation to achieve biventricular pacing without transvenous leads. The protocol tracks procedural success, device- and procedure-related complications, and signals of clinical and electrical efficacy during follow-up. Enrollment includes de novo totally leadless implants and patients selected for reasons such as prior device infection, anatomical constraints, or desire to avoid transvenous leads.

Who should consider this trial

Good fit: Ideal candidates are adults (≥22 years) with heart failure who meet CRT guideline criteria (NYHA II–IV, LVEF ≤35% with qualifying QRS/LBBB patterns) and for whom a totally leadless approach is deemed appropriate.

Not a fit: Patients who do not meet CRT guideline criteria, who require a transvenous defibrillator (CRT‑D), or who cannot undergo implantation at the participating centers are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could provide CRT without transvenous leads, potentially lowering lead-related complications and infection risk.

How similar studies have performed: Prior feasibility work with the WiSE CRT system has demonstrated it can deliver left ventricular pacing and achieve biventricular synchronization, but long-term outcomes and large randomized data remain limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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
* History of chronic alcohol/ drug abuse and currently using alcohol/ drugs
* Non-ambulatory (or unstable) NYHA class 4
* Life expectancy less than 12 months
* 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 enrolled in another clinical study that could confound the results of this study (Note: patients enrolled in complementary study are eligible for enrolment)

Where this trial is running

Birtinya, Queensland and 3 other locations

• Patients of Sunshine Coast University Hospital — Birtinya, Queensland, Australia (NOT_YET_RECRUITING)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (NOT_YET_RECRUITING)
• Patients of Gold Coast University Hospital — Southport, Queensland, Australia (NOT_YET_RECRUITING)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (RECRUITING)

Study contacts

• Principal investigator: Paul Gould, Prof — Princess Alexandra Hospital
• Study coordinator: Christine Phillips

Conditions: Heart Failure