Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy (LBBP-RESYNC)
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|ClinicalTrials.gov Identifier: NCT04110431|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Procedure: Left bundle branch pacing Procedure: Biventricular pacing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Comparison Between Left Bundle Branch Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy in Heart Failure(LBBP-RESYNC)|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: LBBP group
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
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).
Active Comparator: BivP group
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
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
- Echocardiography parameters(LVEF,LVESV and LVEDV) [ Time Frame: Baseline; 6-month follow-up ]Changes in LVEF,LVESV and LVEDV between baseline and follow-up
- Paced QRS duration [ Time Frame: Postoperative day 1; 1-month,3-month and 6-month follow-upP ]Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.
- Changes in concentration of NT-proBNP in blood between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)
- Changes in New York Heart Association Heart Function Classification between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV)
- Changes in 6-minute Walk Distance between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]Distance that a participant walk within 6 minutes
- Change in Quality Of Life Questionnaire score between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome
- Incidence of clinical adverse events [ Time Frame: 6-month follow-up ]Including date and number of all-cause mortality, heart failure hospitalization, cardiovascular hospitalization and malignant ventricular arrhythmia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110431
|Contact: Jiangang Zou, MD,Ph.Demail@example.com|
|The First Affiliated Hospital with Nanjing Medical University|
|Nanjing, Jiangsu, China, 210029|
|Contact: Jiangang Zou, MD,Ph.D 86-13605191407 firstname.lastname@example.org|
|Principal Investigator: Jiangang Zou, MD,Ph.D|
|Fu Wai Hospital, Beijing, China|
|Contact: Xiaohan Fan, MD,Ph.D|
|Principal Investigator:||Jiangang Zou, MD,Ph.D||The First Affiliated Hospital with Nanjing Medical University|