Clinical trial NCT06061627: A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Intraventricular Block
Keywords: Left bundle branch area pacing
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Sir Run Run Shaw Hospital
name: Fu Wai Hospital, Beijing, China
name: West China Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: The First People's Hospital of Yunnan
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Guangdong Provincial People's Hospital
name: Shanghai Tong Ren Hospital
name: Fujian Provincial Hospital
name: Fujian Medical University Union Hospital
First posted: 2023-09-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Left ventricular ejection fraction(LVEF)
timeFrame: Baseline; 6-month follow-up
Secondary outcomes:
measure: Paced QRS duration
timeFrame: Postoperative day 1; 1-month,3-month and 6-month follow-up
measure: A combined clinical endpoint of all-cause mortality and heart failure hospitalization,
timeFrame: 6-month follow-up
measure: Left ventricular end systolic volume(LVESV)
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Left ventricular end diastolic volume(LVEDV)
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Left ventricular end systolic diameter(LVESD)
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Left ventricular end diastolic diameter(LVEDD)
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Change in Quality Of Life Questionnaire score between baseline and follow-up
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Changes in New York Heart Association Heart Function Classification between baseline and follow-up
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Changes in 6-minute Walk Distance between baseline and follow-up
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Changes in concentration of NT-proBNP in blood between baseline and follow-up
timeFrame: Baseline; 3-month, 6-month follow-up
measure: Incidence of stroke events
timeFrame: 6-month follow-up
measure: A combined arrhythmia endpoint of new-onset atrial fibrillation and malignant ventricular arrhythmia
timeFrame: 6-month follow-up
measure: 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
timeFrame: Operative day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jiangang Zou
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Yangang Su
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.