Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization

NCT05155865 | Completed DMC

• 1 other identifier: CSP-SYNC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.

Conditions

Dilated Cardiomyopathy with Conduction Defect; Left Bundle-Branch Block; Heart Failure; Resynchronization Therapy; Cardiac Remodeling, Ventricular

Keywords

left bundle branch block; dilated cardiomyopathy; resynchronization therapy; myocardial work; arrhythmia

Outcome Measures

Primary Outcomes (6)

• Change in left ventricular volume

  Effect on reverse left ventricular remodeling measured as changes in left ventricular volume in both arms

  acute after the procedure, 1 month, 6 months, 12 months

• Change in left ventricular ejection fraction

  Effect on reverse left ventricular remodeling measured as changes in left ventricular ejection fraction in both arms

  acute procedure, 1 month, 6 months, 12 months

• Difference in Heart Failure Class

  From class 1 to 4

  6 months

• Difference in pro-BNP value

  pg/mL

  6 months

• Difference in 6-minute walk test distance

  meters

  6 months

• Difference in the EQ-5D index

  score

  6 months

Secondary Outcomes (7)

• Difference in myocardial work redistribution

  acute after the procedure, 1 month, 6 months, 12 months

• Difference in QRS complex width

  acute after the procedure, 1 month, 6 months, 12 months

• Difference in filtered QRS duration on high-resolution electrocardiogram

  acute after procedure, 1 month, 6 months, 12 months

• Difference in sum absolute QRST integral

  acute after the procedure, 1 month, 6 months, 12 months

• Difference in arrhythmia occurrence

  at least 12 months after enrollment

Study Arms (2)

Resynchronization with conduction system pacing

EXPERIMENTAL

Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs.

Device: Resynchronization with conduction system pacing

Cardiac resynchronization therapy with biventricular stimulation

ACTIVE COMPARATOR

Implantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs.

Device: Cardiac resynchronization therapy with biventricular stimulation

Interventions

Resynchronization with conduction system pacing DEVICE

Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement

Resynchronization with conduction system pacing

Cardiac resynchronization therapy with biventricular stimulation DEVICE

Implantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement

Cardiac resynchronization therapy with biventricular stimulation

Eligibility Criteria

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

You may qualify if:

• Sinus rhythm and complete left bundle branch block according to Strauss criteria
• LVEF ≤35%
• NYHA class II-III
• Optimal medical heart failure therapy for at least 3 months before enrollment
• The patient is able to understand and willing to provide a written informed consent
• years of age or older

You may not qualify if:

• Mechanical tricuspid valve replacement
• More than moderate valvular disease
• Unstable angina, acute MI, CABG, or PCI within the past 6 months
• Persistent or permanent atrial fibrillation
• Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography
• Higher degree AV block
• Life expectancy of less than 12 months
• Pregnancy and breastfeeding
• Acute illness or active systemic infection

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University medical centre Ljubljana

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (11)

• Sharma PS, Vijayaraman P. Conduction System Pacing for Cardiac Resynchronisation. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):51-58. doi: 10.15420/aer.2020.45.

  PMID: 33936744 BACKGROUND

• Herweg B, Welter-Frost A, Vijayaraman P. The evolution of cardiac resynchronization therapy and an introduction to conduction system pacing: a conceptual review. Europace. 2021 Apr 6;23(4):496-510. doi: 10.1093/europace/euaa264.

  PMID: 33247913 BACKGROUND

• Wu S, Su L, Vijayaraman P, Zheng R, Cai M, Xu L, Shi R, Huang Z, Whinnett ZI, Huang W. Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing. Can J Cardiol. 2021 Feb;37(2):319-328. doi: 10.1016/j.cjca.2020.04.037. Epub 2020 May 7.

  PMID: 32387225 BACKGROUND

• Vinther M, Risum N, Svendsen JH, Mogelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Nov;7(11):1422-1432. doi: 10.1016/j.jacep.2021.04.003. Epub 2021 Apr 25.

  PMID: 34167929 BACKGROUND

• Deif B, Ballantyne B, Almehmadi F, Mikhail M, McIntyre WF, Manlucu J, Yee R, Sapp JL, Roberts JD, Healey JS, Leong-Sit P, Tang AS. Cardiac resynchronization is pro-arrhythmic in the absence of reverse ventricular remodelling: a systematic review and meta-analysis. Cardiovasc Res. 2018 Sep 1;114(11):1435-1444. doi: 10.1093/cvr/cvy182.

  PMID: 30010807 BACKGROUND

• Galand V, Singh JP, Leclercq C. Alternative left ventricular pacing approaches for optimal cardiac resynchronization therapy. Heart Rhythm. 2019 Aug;16(8):1281-1289. doi: 10.1016/j.hrthm.2019.03.011. Epub 2019 Mar 16.

  PMID: 30885737 BACKGROUND

• Duchenne J, Aalen JM, Cvijic M, Larsen CK, Galli E, Bezy S, Beela AS, Unlu S, Pagourelias ED, Winter S, Hopp E, Kongsgard E, Donal E, Fehske W, Smiseth OA, Voigt JU. Acute redistribution of regional left ventricular work by cardiac resynchronization therapy determines long-term remodelling. Eur Heart J Cardiovasc Imaging. 2020 Jun 1;21(6):619-628. doi: 10.1093/ehjci/jeaa003.

  PMID: 32031587 BACKGROUND

• Cvijic M, Duchenne J, Unlu S, Michalski B, Aarones M, Winter S, Aakhus S, Fehske W, Stankovic I, Voigt JU. Timing of myocardial shortening determines left ventricular regional myocardial work and regional remodelling in hearts with conduction delays. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):941-949. doi: 10.1093/ehjci/jex325.

  PMID: 29272366 BACKGROUND

• Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.

  PMID: 29535066 BACKGROUND

• Dandamudi G, Vijayaraman P. History of His bundle pacing. J Electrocardiol. 2017 Jan-Feb;50(1):156-160. doi: 10.1016/j.jelectrocard.2016.09.011. Epub 2016 Sep 24.

  PMID: 27720211 BACKGROUND

• Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.

  PMID: 31504425 BACKGROUND

MeSH Terms

Conditions

Idiopathic dilation cardiomyopathy; Bundle-Branch Block; Heart Failure; Ventricular Remodeling; Cardiomyopathy, Dilated; Arrhythmias, Cardiac

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Marta Cvijc, MD

  University Medical Centre Ljubljana (Slovenia)

  STUDY CHAIR

• Anja Zupan Meznar, MD

  University Medical Centre Ljubljana (Slovenia)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. David Žižek, MD, PhD

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: January 10, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)