A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD

Heart Failure Clinical Trial

— BATTLE  

Official title:

A Randomized Controlled Trial of Left Bundle brAnch opTimized Cardiac Resynchronization Therapy Versus conventionaL Bi-vEntricular Pacing in Heart Failure Patients With Nonspecific Intraventricular Conduction Delay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061627
• Other study ID #: FirstNanjingMU005
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: March 2027

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Jiangang Zou
• Phone: 86-13605191407
• Email: jgzou[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment period of 3 years. An LOT-CRT group will be compared with a group of conventional BiVP in the follow-up of at least 6 months. The study aimed to compare the curative effect of LOT-CRT in preserving LV systolic function with traditional BiVP in chronic heart failure patients with NICD.

Description:

Cardiac resynchronization therapy is a standardized treatment strategy for patients with chronic heart failure complicated by wide QRS waves. With the continuous development of physiological pacing technology, traditional cardiac resynchronization therapy, namely biventricular pacing technology, is constantly challenged. Left bundle branch area pacing (LBBAP), as the main method of physiological pacing technology, is currently increasingly widely used in clinical practice. In recent years, research has mainly focused on heart failure patients with wide QRS waves such as non ischemic cardiomyopathy and typical left bundle branch block (LBBB). The recently published LBBP-RESYNC study was a randomized controlled study comparing left bundle branch pacing (LBBP) and biventricular pacing. The results showed that LBBP can achieve better improvement in left ventricular function compared to traditional biventricular pacing.

Compared with patients with typical LBBB, traditional biventricular pacing synchronized treatment is less effective in chronic heart failure patients accompanied by intraventricular block (NICD), which is closely related to the electrophysiological mechanism of LBBB. The blocking site of typical LBBB is generally located within the His bundle to the proximal end of the left bundle branch, while the distal end of the left bundle branch is relatively healthy. Therefore, LBBP can completely correct this type of LBBB and significantly narrow the QRS wave; The electrophysiological mechanism of NICD is relatively complex, and there may be multiple blocking sites, and LBBP cannot be completely corrected. How to improve the treatment efficacy and clinical prognosis of chronic heart failure patients with NICD is an important scientific issue that urgently needs to be solved. It is unclear whether left bundle branch pacing technology can provide support for cardiac function in such patients.

Traditional biventricular pacing combines right ventricular and left epicardial pacing; LBBAP combined with left ventricular epicardial pacing, also known as LOT-CRT, is an innovative pacing method. This study aims to explore the application value of LBBAP in patients with chronic heart failure and NICD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ischemic or non ischemic cardiomyopathy

2. Optimal medical therapy for at lest 3 months

3. NYHA class II-IV

4. LVEF=35% as assessed by echocardiography

5. Sinus rhythm (may have paroxysmal atrial fibrillation)

6. QRS duration = 150ms

7. Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB

Exclusion Criteria:

1. Valvular heart disease that requires or has undergone surgical intervention

2. After mechanical tricuspid valve replacement

3. Persistent or permanent atrial fibrillation or atrial flutter

4. Second or third degree atrioventricular block

5. Have a history of acute myocardial infarction within 3 months prior to enrollment

6. Patient's expected survival time is less than 12 months

7. Pregnant or planned to conceive

8. Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)

9. Patients with simple and persistent left superior vena cava

10. Patients with existing pacemaker implantation

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• LOT-CRT group
In addition to the leads implanted in BiVP group, it is also necessary to implant the left bundle branch area pacing(LBBAP) leads LBBAP includes LBBP and LVSP. LBBP is defined if fulfilling criterion 1 and at least one in criteria 2: Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs); One of the following should be met, while the pacing threshold = 1.5V/0.5ms: Selective LBBP capture pattern appears, with an iso-electrical window between the pacing spike and QRS onset; When reducing the output voltage, the LVAT undergoes a sudden change of>10ms; If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP).
• BiVP group
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (12)

Lead Sponsor

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Fu Wai Hospital, Beijing, China, Fujian Medical University Union Hospital, Fujian Provincial Hospital, Guangdong Provincial People's Hospital, Shanghai Tong Ren Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, The First People's Hospital of Yunnan, West China Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

Jastrzebski M, Moskal P, Huybrechts W, Curila K, Sreekumar P, Rademakers LM, Ponnusamy SS, Herweg B, Sharma PS, Bednarek A, Rajzer M, Vijayaraman P. Left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT): Results from an international LB — View Citation

Wang Y, Zhu H, Hou X, Wang Z, Zou F, Qian Z, Wei Y, Wang X, Zhang L, Li X, Liu Z, Xue S, Qin C, Zeng J, Li H, Wu H, Ma H, Ellenbogen KA, Gold MR, Fan X, Zou J; LBBP-RESYNC Investigators. Randomized Trial of Left Bundle Branch vs Biventricular Pacing for C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction(LVEF)	Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up	Baseline; 6-month follow-up
Secondary	Paced QRS duration	Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.	Postoperative day 1; 1-month,3-month and 6-month follow-up
Secondary	A combined clinical endpoint of all-cause mortality and heart failure hospitalization,	Including date and number of all-cause mortalityand heart failure hospitalization,	6-month follow-up
Secondary	Left ventricular end systolic volume(LVESV)	Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up	Baseline; 3-month, 6-month follow-up
Secondary	Left ventricular end diastolic volume(LVEDV)	Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up	Baseline; 3-month, 6-month follow-up
Secondary	Left ventricular end systolic diameter(LVESD)	Changes from baseline LVESD(unit: mm) assessed by echocardiography at follow-up	Baseline; 3-month, 6-month follow-up
Secondary	Left ventricular end diastolic diameter(LVEDD)	Changes from baseline LVEDD(unit: mm) assessed by echocardiography at follow-up	Baseline; 3-month, 6-month follow-up
Secondary	Change in Quality Of Life Questionnaire score between baseline and follow-up	Reflect the effect of cardiac funtion on quality of life, and higher scores represent a worse outcome	Baseline; 3-month, 6-month follow-up
Secondary	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)	Baseline; 3-month, 6-month follow-up
Secondary	Changes in 6-minute Walk Distance between baseline and follow-up	Distance that a participant walk within 6 minutes	Baseline; 3-month, 6-month follow-up
Secondary	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)	Baseline; 3-month, 6-month follow-up
Secondary	Incidence of stroke events	Including date and number of stroke	6-month follow-up
Secondary	A combined arrhythmia endpoint of new-onset atrial fibrillation and malignant ventricular arrhythmia	Including date and number of new-onset atrial fibrillation and malignant ventricular arrhythmia	6-month follow-up
Secondary	Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation	Success rate of LBBAP in LOT-CRT group	Operative day