NCT05155865Completed
Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization
Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization (CSP-SYNC)
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 30 Nov 2021
- Start date
- 10 Jan 2022
- Primary completion date
- 28 Oct 2024
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Heart failure
- NCT number
- NCT05155865
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 10 Jan 2022 to the primary completion date, 28 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- More than moderate valvular disease
- Unstable angina, acute MI, CABG, or PCI within the past 6 months
- Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography
- Acute illness or active systemic infection
Other
- Mechanical tricuspid valve replacement
- Persistent or permanent atrial fibrillation
- Higher degree AV block
- Life expectancy of less than 12 months
- Pregnancy and breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.