Trials / Unknown
UnknownNCT05549544
Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure
Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Fu Wai Hospital, Beijing, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
Detailed description
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF\<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Left bundle branch area pacing | Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block. |
| DEVICE | Biventricular pacing | Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure |
Timeline
- Start date
- 2022-07-18
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2022-09-22
- Last updated
- 2024-01-10
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05549544. Inclusion in this directory is not an endorsement.