Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05155865
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-11-30
Brief Title:
Conduction System Pacing Versus Biventricular Pacing for Cardiac resYNChronization
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Conduction System Pacing Versus Biventricular Pacing for Cardiac resYNChronization CSP-SYNC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSP-SYNC
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None