A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT (TLC-AU)

February 4, 2026 updated by: EBR Systems, Inc.
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Not yet recruiting
        • Patients of Sunshine Coast University Hospital
        • Contact:
        • Principal Investigator:
          • Naresh Dayananda, Dr
      • Herston, Queensland, Australia, 4006
      • Southport, Queensland, Australia, 4215
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
        • Principal Investigator:
          • Paul Gould, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm, prospective, multicenter, observational study.
.WiSE System therapy ON with Guideline Directed Medical Therapy
Device: WiSE CRT System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Device and procedure related complications.
Time Frame: 1 month and 6 months
Primary Safety
1 month and 6 months
Bi-Ventricular capture on 12 lead EKG
Time Frame: 1 month and 6 months
Performance
1 month and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ejection fraction (EF) from Baseline
Time Frame: 6 months
Secondary efficacy 1
6 months
Change in in left ventricular end systolic volume (LVESV)
Time Frame: 6 months
Secondary efficacy 2
6 months
Change in NYHA class
Time Frame: 6 months
Secondary efficacy 3
6 months
Change in Six-minute walk test
Time Frame: 6 months
Secondary efficacy 4
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EBR Systems, Inc.

Investigators

  • Principal Investigator: Paul Gould, Prof, Princess Alexandra Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-10002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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