Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure :A Multi-center Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients aged more than 18 years old

• Patients diagnosed with heart failure (LVEF\<50%) and have received optimal medical therapy for at least 3 months

• Patients with permanent atrial fibrillation (QRS duration \<130ms) which need ventricular pacing, including:

‣ LVEF\<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures

⁃ LVEF\<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%

• Written informed consent was provided

Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The first affiliated hospital of Nanjing medical university
NOT_YET_RECRUITING
Nanjing
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Contact Information
Primary
Haojie Zhu, M.D
13167310573@163.com
+8613167310573
Backup
Xiaofei Li, M.D
lixiaofei0103@163.com
+8617801013995
Time Frame
Start Date: 2022-07-18
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Experimental: LBBAP group
Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration.
Active_comparator: BiVP group
Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule.
Sponsors
Collaborators: The Second Hospital of Hebei Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University First Hospital, The First Affiliated Hospital with Nanjing Medical University
Leads: Fu Wai Hospital, Beijing, China

This content was sourced from clinicaltrials.gov