Left Bundle Branch Area Pacing in Patients With Heart Failure

NCT06488989 | Active Not Recruiting

• 1 other identifier: Protocol V1 (12.12.2023)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The relevance of Left Bundle Branch Pacing (LBBP) lies in its potential as a promising treatment option for patients with heart failure and left bundle branch block. LBBP aims to restore the normal physiological activation of the heart by delivering electrical impulses to the anatomical area of the left bundle branch, which may lead to more effective and synchronized ventricular contractions. Compared to traditional cardiac resynchronization therapy (CRT), this can result in a more physiological correction of dyssynchrony, improvement in left ventricular pump function, reduction in left ventricular volumes, and a decrease in mitral regurgitation. A crucial criterion is the reduction of heart failure symptoms and the enhancement of the patients quality of life.

Conditions

Heart Failure With Reduced Ejection Fraction; Left Bundle Branch Area Pacing; Heart Failure; Cardiac Resynchronization Therapy; Cardiac Resynchronization Therapy Devices; Conduction System Pacing; Left Bundle-Branch Block

Keywords

heart failure; left bundle branch block; left bundle branch area pacing; medtronic; cardiac resynchronization therapy; kazakhstan

Outcome Measures

Primary Outcomes (9)

• General complications related to implantable cardiac device

  Incidence and amount of participants with general complication (deaths, stroke, thromboembolic complications);

  From enrollment to the end of follow-up period at 12 months

• procedure-related complications related to implantable cardiac device

  Incidence and amount of participants with procedure-related complication (pneumothorax, pocket/wound infection, systemic infection, pocket hematoma, atrial lead dislodgement, pericardial effusion, large vein thrombosis, re-intervention for other non-LBBAP lead reasons, subclavian arteriovenous fistula after puncture)

  From enrollment to the end of follow-up period at 12 months

• LBBAP lead-related complications complications related to implantable cardiac device

  Incidence and amount of patients with LBBAP lead-related complications (intraprocedural perforation into the left ventricle (LV) cavity , delayed perforation into the LV cavity, acute chest pain, acute ST-segment elevation in multiple leads, acute coronary syndrome, coronary vein fistula, coronary artery fistula, painful pacing/chest pain, right bundle branch injury, LBBAP lead unscrewable/trapped/damaged helix, LBBAP lead dislodgement, threshold rise to an absolute value \> 2 V, threshold rise \> 1 V from baseline, threshold rise leading to re-intervention)

  From enrollment to the end of follow-up period at 12 months

• shortening of QRS

  Efficacy will be evaluated by shortening of QRS duration on ECG.

  From enrollment to the end of follow-up period at 12 months

• Improvement of left ventricle ejection fraction

  Efficacy will be evaluated by increasing of left ventricle ejection fraction, measured by transthoracic echocardiography in 4 chamber apical position by Simpson's approach.

  From enrollment to the end of follow-up period at 12 months

• Decreasing of left ventricle end-diastolic diameter

  Efficacy will be evaluated by decreasing of left ventricle end-diastolic diameter measured by transthoracic echocardiography in parasternal long axis.

  From enrollment to the end of follow-up period at 12 months

• Decreasing of left ventricle end-diastolic volume

  Efficacy will be evaluated by decreasing of left ventricle end-diastolic volume measured by transthoracic echocardiography in apical 4-chamber position

  From enrollment to the end of follow-up period at 12 months

• Decreasing of left ventricle end-systolic volume

  Efficacy will be evaluated by decreasing of left ventricle end-systolic volume measured by transthoracic echocardiography in apical 4-chamber position

  From enrollment to the end of follow-up period at 12 months

• Improvement of mitral regurgitation

  Efficacy will be evaluated by decreasing of mitral regurgitation measured by transthoracic echocardiography in multiply positions

  From enrollment to the end of follow-up period at 12 months

Study Arms (1)

patients with heart failure and left bundle branch block

OTHER

1. Male or female ≥ 18 years of age at Visit 1. 2. Patients with complete left bundle branch block, QRS duration greater than 130 ms, left ventricular ejection fraction (LVEF) less than 35%, and New York Heart Association (NYHA) functional class 2-3, who have been ineffective on optimal medical therapy for at least 3 months. 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Device: left bundle branch area pacing

Interventions

left bundle branch area pacing DEVICE

Cardiac resynchronization therapy obtained by conduction system pacing

patients with heart failure and left bundle branch block

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years of age at Visit 1.
• Patients with complete left bundle branch block, QRS duration greater than 130 ms, left ventricular ejection fraction (LVEF) less than 35%, and New York Heart Association (NYHA) functional class 2-3, who have been ineffective on optimal medical therapy for at least 3 months.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

You may not qualify if:

• Pregnancy.
• Psychic disturbances.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data - life expectancy less than 1 year.

Sponsors & Collaborators

• National Research Center for Cardiac Surgery, Kazakhstan: lead

Study Sites (1)

CF UMC

Astana, 010000, Kazakhstan

Location

Related Publications (3)

• Tan JL, Lee JZ, Terrigno V, Saracco B, Saxena S, Krathen J, Hunter K, Cha YM, Russo AM. Outcomes of Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis. CJC Open. 2021 Jun 16;3(10):1282-1293. doi: 10.1016/j.cjco.2021.05.019. eCollection 2021 Oct.

  PMID: 34888508 BACKGROUND

• Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.

  PMID: 24678999 BACKGROUND

• Yu CM, Lin H, Fung WH, Zhang Q, Kong SL, Sanderson JE. Comparison of acute changes in left ventricular volume, systolic and diastolic functions, and intraventricular synchronicity after biventricular and right ventricular pacing for heart failure. Am Heart J. 2003 May;145(5):E18. doi: 10.1016/S0002-8703(03)00071-1.

  PMID: 12766742 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yerlan Turubayev, MD

  doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)