Clinical trial · Interventional
Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block
NCT05553626CI-TRIAL-00061011unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF \<50% and the estimated ventricular pacing percentage \>40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrioventricular Block, Second and Third Degree | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Left Bundle Branch Pacing | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi-ventricular pacing | Device | — | UNRESOLVED |
| Left bundle branch pacing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LBBP Treatment
- description
- Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device
- interventionNames
- Device: Left bundle branch pacing
- Device: Bi-ventricular pacing
- type
- ACTIVE_COMPARATOR
- label
- BVP Treatment
- description
- Patients were performed bi-ventricular pacing by a CRT/CRTD device
- interventionNames
- Device: Left bundle branch pacing
- Device: Bi-ventricular pacing
Primary outcomes (1)
- measure
- Change of LVEF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Above 18 years old * Agree to participate in trial and sign informed consent * NYHA cardiac function class I-III * LVEF\<50% * Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage \>40% * Patients who are willing to take the de-novo implant or device replacement or upgrade. Exclusion Criteria: * Life expectancy \<1 year * Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery * Acute myocardial infarction within 1 month * Women of childbearing age who are pregnant or becoming pregnant during the study period * Severe liver and kidney dysfunction2 * Have been enrolled in another clinical studies that may interferes with the current trial objectives * Evidence of severe pulmonary hypertension (PASP\>70mmHg) * Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients. * The investigator believes that subject's physical condition is not suitable for participation in the trial
References
Publications (0)
Data not yet available
No reference posted for this study.