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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06061627

Collaborator

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

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Intraventricular Block	Procedure: LOT-CRT group Procedure: BiVP group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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).
Active Comparator: BiVP group In this arm, an RA lead , an ICD lead and a LV pacing lead are placed.	Procedure: BiVP group Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

Arm

Intervention/Treatment

Experimental: 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.

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).

Active Comparator: BiVP group

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

Procedure: BiVP group

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

Outcome Measures

Primary Outcome Measures

Left ventricular ejection fraction(LVEF) [Baseline; 6-month follow-up]
Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up

Secondary Outcome Measures

Paced QRS duration [Postoperative day 1; 1-month,3-month and 6-month follow-up]
Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.
A combined clinical endpoint of all-cause mortality and heart failure hospitalization, [6-month follow-up]
Including date and number of all-cause mortalityand heart failure hospitalization,
Left ventricular end systolic volume(LVESV) [Baseline; 3-month, 6-month follow-up]
Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up
Left ventricular end diastolic volume(LVEDV) [Baseline; 3-month, 6-month follow-up]
Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up
Left ventricular end systolic diameter(LVESD) [Baseline; 3-month, 6-month follow-up]
Changes from baseline LVESD(unit: mm) assessed by echocardiography at follow-up
Left ventricular end diastolic diameter(LVEDD) [Baseline; 3-month, 6-month follow-up]
Changes from baseline LVEDD(unit: mm) assessed by echocardiography at follow-up
Change in Quality Of Life Questionnaire score between baseline and follow-up [Baseline; 3-month, 6-month follow-up]
Reflect the effect of cardiac funtion on quality of life, and higher scores represent a worse outcome
Changes in New York Heart Association Heart Function Classification between baseline and follow-up [Baseline; 3-month, 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 [Baseline; 3-month, 6-month follow-up]
Distance that a participant walk within 6 minutes
Changes in concentration of NT-proBNP in blood between baseline and follow-up [Baseline; 3-month, 6-month follow-up]
Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)
Incidence of stroke events [6-month follow-up]
Including date and number of stroke
A combined arrhythmia endpoint of new-onset atrial fibrillation and malignant ventricular arrhythmia [6-month follow-up]
Including date and number of new-onset atrial fibrillation and malignant ventricular arrhythmia
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 [Operative day]
Success rate of LBBAP in LOT-CRT group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jiangang Zou, The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Yangang Su, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT06061627

Other Study ID Numbers:

FirstNanjingMU005

First Posted:

Sep 29, 2023

Last Update Posted:

Sep 29, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The First Affiliated Hospital with Nanjing Medical University

Left bundle branch area pacing

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Sep 29, 2023