Trial · NCT07879716
Belgo-Luxembourg Leadless PM Registry
NCT07879716, Not applicable, Not yet recruiting, Universitaire Ziekenhuizen KU Leuven
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Belgo-Luxembourg Leadless PM Registry. Trials, record NCT07879716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07879716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belgo-Luxembourg Leadless PM Registry
- NCT number
- NCT07879716
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 190 participants, estimated
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker, Pacemaker Complication, Sick Sinus Node Syndrome
- Interventions
- CT scan heart, 24 hour ambulatory ECG monitoring
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of safety | 1/6-month, 1-year and 2-year | The primary safety endpoint is 1/6-month, 1-year and 2-year incidence rate of leadless device-related or procedure-related major complications. In this context, the implant procedure will also be summarized. Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision. |
| Primary | Assesment of Electrical Efficacy: capture threshold | 12 and 24 month FU | Ventricular pacing threshold is considered acceptable if \<2.0 V at 0.4 ms Atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms |
| Primary | Assesment of Electrical Efficacy: R-wave and P-wave amplitude | 12 and 24 month FU | R-wave amplitude is considered acceptable if \>5.0 mV P-wave amplitude is considered adequate if ≥1.0 mV. |
| Primary | Assesment of Efficacy: i2i communication betwoon both pacemakers | 12 and 24 month FU | Acceptable i2i communication is defined as \>80% in AVEIR DR systems as measured. |
| Primary | AV synchrony and i2i communication in patients with high-degree AV block. | 12-months | The i2i communication between both devices will be also specifically assessed in patients treated with Aveir DR for permanent high degree AV block (\>80% VP). This will be validated by the acquisition of an ambulatory holter at the 12-month follow-up. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07879716
GET https://conductscience.org/api/trials/v1/NCT07879716/registered