An interventional study of Left bundle branch pacing and Biventricular pacing in Chronic Heart Failure, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
The present study will recruit 40 symptomatic heart failure patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block(QRSd≥130 ms). Each patient was randomized to either left bundle branch pacing(LBBP) or biventricular pacing(BivP) and was followed up for at least 6 months. The objective is to compare the effects of LBBP and BivP on cardiac resynchronization in the treatment of heart failure by measurable clinical parameters.
The traditional biventricular pacing (BivP) is an established treatment to corrected the cardiac dyssynchrony in heart failure patients with left bundle branch block(LBBB). It has been proved that BivP can improve clinical symptoms and reduce all-cause mortality in heart failure. However, BivP is subject to the variable coronary sinus(CS) anatomy and LV-pacing lead fail to be implanted in 5%-10% of patients due to the lack of appropriate target branch, high threshold or phrenic nerve stimulation. Almost 30%-40% of patients with successful implantation show no response. What's more, BivP just corrects the mechanical dyssynchrony caused by LBBB not corrects the LBBB. Recent studies have demonstrated that His bundle pacing (HBP) can correct LBBB, achieve physiological pacing and realize the cardiac resynchronization. But HBP has high technical requirements, lower sense value and higher threshold of correcting LBBB, which may be further increased in long-term follow-up.
The lastest research shows that pacing left ventricular septum using a transseptal approach can reduce left ventricular(LV) electrical dyssynchrony. Huang et al first confirmed that left bundle branch pacing(LBBP) can correct LBBB and improve cardiac function. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP. In chronic heart failure patients with LBBB that need cardiac resynchronization therapy(CRT), LBBP can achieve the similar electrical and mechanical resynchronization as well as HBP.
There is to date no randomized studies between LBBP and BivP in HFrEF patients with complete LBBB that need CRT. The purpose of this study is to compare the therapeutic effects of LBBP and conventional BivP on LV function and clinical endpoints in such patients. The present study will randomize 40 patients in two centres to LBBP or BivP. Baseline assessments including echocardiography parameters[left ventricular ejection fraction(LVEF ), left ventricular end-systolic volume(LVESV), left ventricular end-diastolic volume(LVEDV)], electrocardiogram(ECG), N-terminal pro B-type natriuretic peptide(NT-proBNP) level, New York Heart Association(NYHA) class, 6-minute walking distance(6MWD) and quality of life score(QOL) will be obtained. At the same time, the LBBP and BivP success rate, intraoperative and postoperative complications are recorded.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
In this arm, An right artrial (RA) lead and an implantable cardioverter defibrillator (ICD) lead are conventionally implanted. A left bundle branch pacing(LBBP) lead is attempted to be placed. If LBBP failed, a left ventricular(LV) pacing lead is implanted instead.
Procedure: Left bundle branch pacing
In this arm, an RA lead , an ICD lead and a LV pacing lead are placed. If the implantation of LV pacing lead is unsuccessful due to unavailable coronary sinus branches(venae cordis magna or venae cordis media is not recommended), capture above 3.5V/0.5ms or refractory phrenic nerve stimulation,a LBBP lead is placed instead.
Procedure: Biventricular pacing
Successful LBBP was defined as (1) LBBP lead is located at 1.5-2cm from His-bundle towards right ventricular apex; (2) Paced QRS morphology of right bundle branch delay(CRBBD) in lead V1; (3) Stimulus to the peak of R wave in V5 and V6 QRS wave, which represents left ventricular activation time(Stim-LVAT), is less than 100ms and constant at high and low output pacing; (4) Unipolar pacing threshold\<1.5V/0.5ms; (5) Recording P potential when narrow QRS escape rhythm or CRBBB escape rhythm(not essential).
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
Echocardiography parameters(LVEF,LVESV and LVEDV)
Changes in LVEF,LVESV and LVEDV between baseline and follow-up
Time frame: Baseline; 6-month follow-up
Paced QRS duration
Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.
Time frame: Postoperative day 1; 1-month,3-month and 6-month follow-upP
Changes in concentration of NT-proBNP in blood between baseline and follow-up
Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)
Time frame: Baseline; 1-month,3-month and 6-month follow-up
Changes in New York Heart Association Heart Function Classification between baseline and follow-up
The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV)
Time frame: Baseline; 1-month,3-month and 6-month follow-up
Changes in 6-minute Walk Distance between baseline and follow-up
Distance that a participant walk within 6 minutes
Time frame: Baseline; 1-month,3-month and 6-month follow-up
Change in Quality Of Life Questionnaire score between baseline and follow-up
Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome
Time frame: Baseline; 1-month,3-month and 6-month follow-up
Incidence of clinical adverse events
Including date and number of all-cause mortality, heart failure hospitalization, cardiovascular hospitalization and malignant ventricular arrhythmia
Time frame: 6-month follow-up
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University