Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088927
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-05-12
Brief Title:
Long-term Outcomes of Conduction System Pacing a National Multicenter Observational Study - NORMANDHIS STIMUHIS
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Long-term Outcomes of Conduction System Pacing a National Multicenter Observational Study - NORMANDHIS STIMUHIS
Status:
RECRUITING
Status Verified Date:
2023-03
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:
STIMUHIS
Brief Summary:
This prospective multicenter registry will evaluate the long-term electrical echocardiographic and clinical outcomes of conduction system pacing CSP There is currently limited data in the literature regarding the long-term results and benefits of CSP The long-term maintenance of conduction system His bundle or Left Bundle Branch capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique
There is currently no prospective study evaluating the preservation of CSP during long-term follow-up The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up The prospective collection of electrical data pacing thresholds impedance R wave sensing during pacemaker follow-up visits will confirm thresholds stability over the long term The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker
Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction LVEF after CSP This systematic follow-up is rarely found in CSP studies often retrospective with significant missing echocardiographic data The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing such as left ventricular dilation and LVEF impairment Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiographyFinally this prospective cohort will also systematically collect clinical follow-up data hospitalizations for heart failure and NYHA stage
There is currently no prospective study evaluating the preservation of CSP during long-term follow-up The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up The prospective collection of electrical data pacing thresholds impedance R wave sensing during pacemaker follow-up visits will confirm thresholds stability over the long term The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker
Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction LVEF after CSP This systematic follow-up is rarely found in CSP studies often retrospective with significant missing echocardiographic data The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing such as left ventricular dilation and LVEF impairment Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiographyFinally this prospective cohort will also systematically collect clinical follow-up data hospitalizations for heart failure and NYHA stage
Detailed Description:
None
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