Heart FailureTLC-AUNCT06561932
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
A study testing WiSE CRT System in people with Heart Failure, run by EBR Systems, Inc. at 4 sites in Australia.
Trial summary
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- WiSE CRT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesAustralia
- Study dates
- 18 Dec 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Recruiting
Patients of Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Samantha Wadham, Samantha.Wadham@health.qld.gov.au
Naresh Dayananda, Dr
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Leanne Palethorp, Leanne.Palethorp@health.qld.gov.au
Paul Martin, Dr
- Recruiting
Patients of Gold Coast University Hospital
Southport, Queensland, 4215
Lynley Schostakowsky, Lynley.Schostakowski@health.qld.gov.au
Robert Park, Dr
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Cindy Hall, cindy.hall@health.qld.gov.au
Paul Gould, Professor
About this study
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- WiSE CRT System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiSE CRT SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, prospective, multicenter, observational study. | Experimental | .WiSE System therapy ON with Guideline Directed Medical Therapy Receives: Device: WiSE CRT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device and procedure related complications.
Primary Safety
Measured: 1 month and 6 months
Bi-Ventricular capture on 12 lead EKG
Performance
Measured: 1 month and 6 months
Secondary outcomes (4)
Change in ejection fraction (EF) from Baseline
Secondary efficacy 1
Measured: 6 months
Change in in left ventricular end systolic volume (LVESV)
Secondary efficacy 2
Measured: 6 months
Change in NYHA class
Secondary efficacy 3
Measured: 6 months
Change in Six-minute walk test
Secondary efficacy 4
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Dec 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, multicenter, observational study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EBR Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Gould, Prof, Principal investigator, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561932
- Sponsor's protocol ID
- CSP-10002
- Acronym
- TLC-AU
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
- ClinicalTrials.gov ID
- NCT06561932
- Acronym / sponsor ID
- TLC-AU / CSP-10002
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- EBR Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, multicenter, observational study.
| Arm | Type | Receives |
|---|---|---|
| Single-arm, prospective, multicenter, observational study. | Experimental | Device: WiSE CRT System.WiSE System therapy ON with Guideline Directed Medical Therapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)):
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WiSE CRT SystemThe 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. | Device | Single-arm, prospective, multicenter, observational study. |
Primary outcome
Incidence of Device and procedure related complications.
Time frame: 1 month and 6 months
Primary Safety
Bi-Ventricular capture on 12 lead EKG
Time frame: 1 month and 6 months
Performance
4 secondary outcomes
Change in ejection fraction (EF) from Baseline
Time frame: 6 months
Change in in left ventricular end systolic volume (LVESV)
Time frame: 6 months
Change in NYHA class
Time frame: 6 months
Change in Six-minute walk test
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Gould, Prof principal investigator
Princess Alexandra Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WiSE CRT System in people with Heart Failure, run by EBR Systems, Inc. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Burke (408-720-1906, clinical@ebrwise.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device and procedure related complications. (time frame: 1 month and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.