If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Study for people with Heart Disease
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Patients of Sunshine Coast University Hospital | Birtinya | QLD | Recruiting |
| Royal Brisbane and Women's Hospital | Herston | QLD | Recruiting |
| Patients of Gold Coast University Hospital | Southport | QLD | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | QLD | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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)
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 14 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.