Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization (CSP-SYNC)

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The proposed inclusion criteria represent the minimum recommendations for CRT implantation according to the ESC 2021 guidelines. In addition:

• 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

• 18 years of age or older

Locations
Other Locations
Slovenia
University medical centre Ljubljana
Ljubljana
Time Frame
Start Date: 2022-01-10
Completion Date: 2024-10-28
Participants
Target number of participants: 62
Treatments
Experimental: 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.
Active_comparator: 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.
Authors
Marta Cvijc, Anja Zupan Meznar
Sponsors
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov

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