Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05467163
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-07-17
Brief Title:
Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
CONDUCTion System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation in Heart Failure Patients With Symptomatic Atrial Fibrillation and Narrow QRS CONDUCT-AF Trial
Status:
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:
CONDUCT-AF
Brief Summary:
Atrioventricular node ablation AVNA with biventricular BiV pacemaker implantation is a feasible treatment option in patients with symptomatic refractory atrial fibrillation and heart failure However conduction system pacing CSP modalities including His bundle pacing and left bundle branch pacing could offer advantages over BiV pacing by providing more physiological activation The randomized interventional multicentric study will explore whether CSP is non-inferior to BiV pacing in echocardiographic and clinical outcomes in heart failure EF 50 patients with symptomatic AF and narrow QRS scheduled for AVNA
Detailed Description:
Atrio-ventricular node ablation AVNA with subsequent permanent pacemaker implantation provides definite rate control and represents an alternative therapeutic approach in patients with symptomatic atrial fibrillation AF and rapid ventricular rate refractory to optimal medical treatment or catheter ablation However optimal pacing modality remains unclear Previous studies have demonstrated that biventricular BiV pacing followed by AVNA resulted in significant reduction in mortality heart failure HF hospitalizations significant improvement in symptoms and left ventricular LV remodeling Although its benefit was much less transparent in patients with narrow QRS and LV impairment as it still causes abnormal cardiac activation with potential worsening of electrical dyssynchrony To avoid the detrimental effects of BiV pacing a new concept conduction system pacing CSP including His bundle Pacing HBP and left bundle branch pacing LBBP was proposed as a potential alternative Both CSP modalities offer advantages over BiV pacing by providing more physiological activation avoiding cardiac dyssynchrony and left ventricular dysfunction Moreover LBBP showed some advantages over HBP Since the lead is implanted in the region of the left bundle which has an adequate distance from the AVNA site this modality could minimize the risk of increase in capture threshold after AVNA Additionally the pacing parameters of LBBP were stable in long-term follow-up studies precluding the need for back-up pacing Therefore compared to HBP and BiV pacing LBBP may offer a more feasible physiologic pacing option to be adopted into clinical practice Some observational studies have already shown positive outcomes of HBP and LBBP in symptomatic AF patients who underwent AVNA with the favorable clinical and echocardiographic improvement compared to BIV pacing especially in HF patients with narrow baseline QRS and reduced ejection fraction EF50 However prospective randomized study evaluating the value of CSP as an alternative approach to BiV pacing in combination with AVNA is lacking
The purpose of this study is to compare the effects of CSP and conventional BiV pacing on echocardiographic and clinical outcomes in HF patients with symptomatic AF and narrow QRS scheduled for AVNA In this multicentric study 82 patients will be randomized into one of two arms a BiV pacing arm with BiV pacemaker implantation AVNA or CSP arm with the implantation of a CSP device AVNA In patients randomized in CSP group LBBP will be the preferred pacing technique If LBBP will be unobtainable HBP implantation will be attempted In both arms additional defibrillator backup will be implanted at the discretion of the physician according to the ESC guidelines In short-term analysis after 6 months echocardiographic laboratory and symptomatic parameters will be evaluated Long-term analysis to assess HF hospitalization cardiovascular mortality and pacing parameters will be performed after at least 24 months of follow-up
Investigators hypothesize that CSP could represent a feasible and safe alternative to BiV pacing in terms of clinical and echocardiographic outcomes
The purpose of this study is to compare the effects of CSP and conventional BiV pacing on echocardiographic and clinical outcomes in HF patients with symptomatic AF and narrow QRS scheduled for AVNA In this multicentric study 82 patients will be randomized into one of two arms a BiV pacing arm with BiV pacemaker implantation AVNA or CSP arm with the implantation of a CSP device AVNA In patients randomized in CSP group LBBP will be the preferred pacing technique If LBBP will be unobtainable HBP implantation will be attempted In both arms additional defibrillator backup will be implanted at the discretion of the physician according to the ESC guidelines In short-term analysis after 6 months echocardiographic laboratory and symptomatic parameters will be evaluated Long-term analysis to assess HF hospitalization cardiovascular mortality and pacing parameters will be performed after at least 24 months of follow-up
Investigators hypothesize that CSP could represent a feasible and safe alternative to BiV pacing in terms of clinical 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