The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
NCT Number: NCT06061627
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP).
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
Time frame: Baseline; 6-month follow-up
Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up
Time frame: 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.
Time frame: 6-month follow-up
Including date and number of all-cause mortalityand heart failure hospitalization,
Time frame: Baseline; 3-month, 6-month follow-up
Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up
Time frame: Baseline; 3-month, 6-month follow-up
Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up
Time frame: Baseline; 3-month, 6-month follow-up
Changes from baseline LVESD(unit: mm) assessed by echocardiography at follow-up
Time frame: Baseline; 3-month, 6-month follow-up
Changes from baseline LVEDD(unit: mm) assessed by echocardiography at follow-up
Time frame: Baseline; 3-month, 6-month follow-up
Reflect the effect of cardiac funtion on quality of life, and higher scores represent a worse outcome
Time frame: 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)
Time frame: Baseline; 3-month, 6-month follow-up
Distance that a participant walk within 6 minutes
Time frame: 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)
Time frame: 6-month follow-up
Including date and number of stroke
Time frame: 6-month follow-up
Including date and number of new-onset atrial fibrillation and malignant ventricular arrhythmia
Time frame: Operative day
Success rate of LBBAP in LOT-CRT group
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital with Nanjing Medical University
Other
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
Acronym: BATTLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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