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

NCT06061627 | Recruiting DMC

• 1 other identifier: FirstNanjingMU005
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Intraventricular Block

Keywords

Left bundle branch area pacing

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction(LVEF)

  Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up

  Baseline; 6-month follow-up

Secondary Outcomes (13)

• Paced QRS duration

  Postoperative day 1; 1-month,3-month and 6-month follow-up

• A combined clinical endpoint of all-cause mortality and heart failure hospitalization,

  6-month follow-up

• Left ventricular end systolic volume(LVESV)

  Baseline; 3-month, 6-month follow-up

• Left ventricular end diastolic volume(LVEDV)

  Baseline; 3-month, 6-month follow-up

• Left ventricular end systolic diameter(LVESD)

  Baseline; 3-month, 6-month follow-up

Study Arms (2)

LOT-CRT group

EXPERIMENTAL

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.

Procedure: LOT-CRT group

BiVP group

ACTIVE COMPARATOR

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

Procedure: BiVP group

Interventions

LOT-CRT group 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).

LOT-CRT group

BiVP group PROCEDURE

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

BiVP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or non ischemic cardiomyopathy
• Optimal medical therapy for at lest 3 months
• NYHA class II-IV
• LVEF≤35% as assessed by echocardiography
• Sinus rhythm (may have paroxysmal atrial fibrillation)
• QRS duration ≥ 150ms
• Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB

You may not qualify if:

• Valvular heart disease that requires or has undergone surgical intervention
• After mechanical tricuspid valve replacement
• Persistent or permanent atrial fibrillation or atrial flutter
• Second or third degree atrioventricular block
• Have a history of acute myocardial infarction within 3 months prior to enrollment
• Patient's expected survival time is less than 12 months
• Pregnant or planned to conceive
• Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)
• Patients with simple and persistent left superior vena cava
• Patients with existing pacemaker implantation

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 36137670 RESULT

• 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.

  PMID: 34339851 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jiangang Zou

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Yangang Su

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiangang Zou

CONTACT

86-13605191407; jgzou@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)