Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization

NCT ID: NCT05155865

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2024-10-28

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.

Detailed Description

Cardiac resynchronization therapy (CRT) with biventricular pacing is an integral part of heart failure therapy in patients with reduced ejection fraction and wide QRS. Previous studies have demonstrated improved quality of life, reduced heart failure hospitalization, and decreased all-cause mortality. However, approx. 30% of patients still do not benefit from this therapy. High pacing thresholds and phrenic nerve stimulation are also common problems with BiV stimulation. Newer CRT systems with improved programmability and algorithms in conjunction with quadripolar left ventricular leads have solved some challenges of BiV pacing. However, BiV stimulation with non-physiological epicardial activation has shown a possible pro-arrhythmic effect which is more pronounced in the non-responder population.

On the other hand, CSP provides synchronous physiological ventricular activation with possible superior electrical and mechanical resynchronization compared to BiV pacing. Electrical activation maps obtained during CSP showed normalization of left bundle branch block with more homogeneous electrical resynchronization than in biventricular pacing. Additionally, BiV CRT effectively corrects mechanical dyssnchrony, demonstrated with homogenization of myocardial work. This has already been proven as the underlying pathophysiological mechanism for successful CRT response. However, the effect of CSP on echocardiographic parameters of mechanical dyssynchrony is not known.

Previous studies of CSP focused on feasibility and its benefits over right ventricular pacing in patients with refractory atrial fibrillation who underwent atrioventricular node ablation and pacemaker implantation. Promising results were followed by the acknowledgment of this physiological mode of pacing by the recent guidelines of European Society of Cardiology. However, studies evaluating the value of CSP as an alternative approach to BiV CRT in heart failure patients are limited. The purpose of this study is to compare the effects of CSP and conventional BiV pacing on electrocardiographic and echocardiographic parameters as well as on clinical outcomes in patients with heart failure with reduced ejection fraction (LVEF ≤35%), sinus rhythm, and left bundle branch block. In this single-center study, 60 patients will be randomized into one of two arms: a BiV pacing arm with BiV CRT implantation based on clinical guidelines or an experimental CSP arm with the implantation of a CSP device. Device with a defibrillator (ICD) will be selected at the discretion of the implanting physician. Baseline and follow up assessments will include clinical evaluation (New York Heart Association class, 6-minute walking distance), evaluation of quality of life (EQ-5D index), laboratory tests (N-terminal pro-B-type natriuretic peptide), electrocardiographic recordings (standard 12-leads ECG and high-resolution-ECG), and echocardiographic evaluation (standard echocardiographic parameters of LV reverse remodeling and non-invasive myocardial work assessment). Intra-operative and procedural parameters will also be recorded.

Investigators hypothesize that CSP could represent a feasible and safe alternative to conventional BiV pacing in terms of clinical, electrocardiographic, and echocardiographic outcomes.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resynchronization with conduction system pacing

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.

Group Type: EXPERIMENTAL

Resynchronization with conduction system pacing

Intervention Type: DEVICE

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

Cardiac resynchronization therapy with biventricular stimulation

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

Group Type: ACTIVE_COMPARATOR

Cardiac resynchronization therapy with biventricular stimulation

Intervention Type: DEVICE

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

Interventions

Resynchronization with conduction system pacing

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

Intervention Type: DEVICE

Cardiac resynchronization therapy with biventricular stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Sinus rhythm and complete left bundle branch block according to Strauss criteria

2. LVEF ≤35%

3. NYHA class II-III

4. Optimal medical heart failure therapy for at least 3 months before enrollment

5. The patient is able to understand and willing to provide a written informed consent

6. 18 years of age or older

Exclusion Criteria

1. Mechanical tricuspid valve replacement

2. More than moderate valvular disease

3. Unstable angina, acute MI, CABG, or PCI within the past 6 months

4. Persistent or permanent atrial fibrillation

5. Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography

6. Higher degree AV block

7. Life expectancy of less than 12 months

8. Pregnancy and breastfeeding

9. Acute illness or active systemic infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

David Žižek, MD, PhD

assist. prof. David Žižek, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Cvijc, MD

Role: STUDY_CHAIR

University Medical Centre Ljubljana (Slovenia)

Anja Zupan Meznar, MD

Role: STUDY_CHAIR

University Medical Centre Ljubljana (Slovenia)

Locations

University medical centre Ljubljana

Ljubljana, Slovenia, Slovenia

Countries

Slovenia

References

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Other Identifiers

CSP-SYNC

Identifier Type: -

Identifier Source: org_study_id