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Heart FailureBATTLENCT06061627

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

A study testing LOT-CRT group and BiVP group in people with Heart Failure and Intraventricular Block, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Intraventricular Block
What is being tested?
LOT-CRT group and BiVP group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
21 Sep 2023to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiangang Zou contact

86-13605191407

jgzou@njmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Jiangang Zou, +8613605191407, jgzou@njmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
LOT-CRT group, BiVP group
Keywords
Left bundle branch area pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LOT-CRT groupProcedure or surgery

    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:
    3. Selective LBBP capture pattern appears, with an iso-electrical window between the pacing spike and QRS onset;
    4. 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 groupProcedure or surgery

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

Study groups in NCT06061627
Study groupRoleWhat they receive
LOT-CRT groupExperimentalIn 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.
Receives: Procedure: LOT-CRT group
BiVP groupActive comparatorIn this arm, an RA lead , an ICD lead and a LV pacing lead are placed.
Receives: Procedure: BiVP group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction(LVEF)

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

    Measured: Baseline; 6-month follow-up

Secondary outcomes (13)

  1. Paced QRS duration

    Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.

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

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

    Including date and number of all-cause mortalityand heart failure hospitalization,

    Measured: 6-month follow-up

  3. Left ventricular end systolic volume(LVESV)

    Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up

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

  4. Left ventricular end diastolic volume(LVEDV)

    Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up

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

  5. Left ventricular end systolic diameter(LVESD)

    Changes from baseline LVESD(unit: mm) assessed by echocardiography at follow-up

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

  6. Left ventricular end diastolic diameter(LVEDD)

    Changes from baseline LVEDD(unit: mm) assessed by echocardiography at follow-up

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

  7. 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

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

  8. 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)

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

  9. Changes in 6-minute Walk Distance between baseline and follow-up

    Distance that a participant walk within 6 minutes

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

  10. 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)

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

  11. Incidence of stroke events

    Including date and number of stroke

    Measured: 6-month follow-up

  12. 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

    Measured: 6-month follow-up

  13. 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

    Measured: Operative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start21 Sep 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061627
Sponsor's protocol ID
FirstNanjingMU005
Acronym
BATTLE
Status last verified
May 2026
First submitted
25 Sep 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36137670

  • 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.

    PubMed 34339851

Questions about this trial

What is this clinical trial studying?

A study testing LOT-CRT group and BiVP group in people with Heart Failure and Intraventricular Block, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiangang Zou (86-13605191407, jgzou@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction(LVEF) (time frame: Baseline; 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061627, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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