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

NCT ID: NCT06061627

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2027-03-31

Brief 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.

Detailed 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.

Conditions

Heart Failure; Intraventricular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LOT-CRT group

In this arm, an right artrial (RA) lead, an implantable cardioverter defibrillator (ICD) lead and a LV pacing lead are placed are conventionally implanted.

A left bundle branch pacing(LBBP) lead is attempted to be placed.

Group Type: EXPERIMENTAL

LOT-CRT group

Intervention Type: PROCEDURE

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:

1. Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs);

2. One of the following should be met, while the pacing threshold ≤ 1.5V/0.5ms:

1. Selective LBBP capture pattern appears, with an iso-electrical window between the pacing spike and QRS onset;

2. 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

In this arm, an RA lead , an ICD lead and a LV pacing lead are placed.

Group Type: ACTIVE_COMPARATOR

BiVP group

Intervention Type: PROCEDURE

Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

Interventions

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:

1. Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs);

2. One of the following should be met, while the pacing threshold ≤ 1.5V/0.5ms:

1. Selective LBBP capture pattern appears, with an iso-electrical window between the pacing spike and QRS onset;

2. 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).

Intervention Type: PROCEDURE

BiVP group

Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tong Ren Hospital

OTHER

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiangang Zou

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Yangang Su

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiangang Zou

Role: CONTACT

jgzou@njmu.edu.cn

86-13605191407

Facility Contacts

Jiangang Zou

Role: primary

jgzou@njmu.edu.cn

+8613605191407

References

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 Cardiac Resynchronization Therapy. J Am Coll Cardiol. 2022 Sep 27;80(13):1205-1216. doi: 10.1016/j.jacc.2022.07.019.

Reference Type: RESULT

PMID: 36137670 (View on PubMed)

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 LBBAP collaborative study group. Heart Rhythm. 2022 Jan;19(1):13-21. doi: 10.1016/j.hrthm.2021.07.057. Epub 2021 Jul 30.

Reference Type: RESULT

PMID: 34339851 (View on PubMed)

Other Identifiers

FirstNanjingMU005

Identifier Type: -

Identifier Source: org_study_id