Trial · NCT07909239
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
NCT07909239, Not applicable, Not yet recruiting, University Hospital, Clermont-Ferrand
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI. Trials, record NCT07909239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
- NCT number
- NCT07909239
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 700 participants, estimated
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block, Reduced Left Ventricular Ejection Fraction
- Interventions
- Left bundle branch area pacing with pacemaker, Implantation loop recorder
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The first occurrence of one of the following events : hospitalization for worsening heart failure, episode of syncope or dizziness, high-grade atrioventricular conduction disturbance) | From randomization to 12 follow up | The primary efficacy endpoint is a composite clinical outcome evaluated at 12 months after randomization, defined as the first occurrence of one of the following events: 1. Hospitalization for worsening heart failure, 2. Episode of syncope or dizziness, 3. High-grade atrioventricular conduction disturbance (second-degree AV block type II or third-degree AV block requiring implantation of a permanent pacemaker, documented \> 3 seconds on ILR or ECG)). The composite endpoint will be analyzed as time-to-event data with death considered as a competing risk. |
| Secondary | Incidence of atrial fibrillation, ventricular tachycardia, non-sustained ventricular tachycardia | At 6,12, 24 and 36 months after randomization | |
| Secondary | Evolution of LVEF | At 6,12, 24 and 36 months after randomization | Measurement of LVEF at inclusion and at each follow-up time point. The change in LVEF over time will be assessed relative to the date of inclusion and the preceding time point. |
| Secondary | Evolution of Quality of life (EQ-5D) | At 6, 12, 24 and 36 months after randomization | Measurement of EQ-5D at inclusion and at each follow-up time point. The change in EQ-5D over time will be assessed relative to the date of inclusion and the preceding time point. |
| Secondary | Incidence of Hospitalizations (all-cause, cardiovascular, HF-related) | At 6, 12, 24 and 36 months after randomization | |
| Secondary | Incidence of Mortality (all-cause, cardiovascular, HF-related) | At 6, 12, 24 and 36 months after randomization | Measurement of the cumulative incidence of all-cause, cardiovascular, and heart failure-related mortality at 6, 12, 24, and 36 months after randomization, based on the occurrence and documented cause of death. |
| Secondary | Medico-economic evaluation | At 6, 12, 24 and 36 months after randomization | |
| Secondary | Complications related to pacemaker or ILR implantation | At 6, 12, 24 and 36 months after randomization | |
| Secondary | Unscheduled pacemaker implantation in the ILR group | At 6, 12, 24 and 36 months after randomization |
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/NCT07909239
GET https://conductscience.org/api/trials/v1/NCT07909239/registered