Tiny pacemaker without wires tested in 20 patients
NCT ID NCT07287423
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study is testing a new type of pacemaker that doesn't use wires (leads) to help control slow heart rhythms. About 20 adults who need a pacemaker will get this device and be checked for safety and how well it works at 1 and 3 months. The goal is to see if this leadless system can pace the heart effectively with fewer complications.
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
-
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
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Subject must have at least one standard pacemaker indication 2. Subject must be at least 18 years of age 3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams 4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC Exclusion Criteria: 1. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter 2. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure 3. Subject has previous myocardial infarction 4. Subject is expected to be pacemaker dependent 5. Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices) 6. Subject has an active implantable electronic device that cannot be turned off during the study procedure 7. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment 8. Subject has known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure 9. Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 10. Subject has known chronic renal insufficiency including patients on dialysis 11. Subject has an active systemic infection 12. Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect 13. Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation 14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements of the clinical investigation 16. Subject is unable to read or write
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bradycardia are added.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Locations
-
Nemocnice Na Homolce
RECRUITINGPrague, Czechia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why do some children arrive at the ER with a racing or skipping heart?
- A temporary wire that keeps hearts beating on cue
- Can a video get heart device patients moving more?
- Why do some hearts slow down after pulsed field ablation?
- Which pacing target keeps the heart stronger? a trial aims to find out
- Can a pacemaker slip in through the neck vein?