Wireless heart device could replace wires in heart failure treatment
NCT ID NCT06561932
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new wireless system that helps the heart beat in sync for people with heart failure. About 40 participants will get a special pacemaker and a wireless receiver to improve heart function without traditional wires. The goal is to see if the device is safe and can improve heart pumping and daily life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Patients of Gold Coast University Hospital
NOT_YET_RECRUITINGSouthport, Queensland, 4215, Australia
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Patients of Sunshine Coast University Hospital
NOT_YET_RECRUITINGBirtinya, Queensland, 4575, Australia
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Princess Alexandra Hospital
RECRUITINGWoolloongabba, Queensland, 4102, Australia
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Royal Brisbane and Women's Hospital
NOT_YET_RECRUITINGHerston, Queensland, 4006, Australia
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