Actively Recruiting
Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Led by University Hospital, Rouen · Updated on 2023-10-18
2500
Participants Needed
10
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).
CONDITIONS
Official Title
Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who had undergone conduction system pacing attempt
- Age > 18 yo
- Capacity to understand the nature of the study, legal ability and willingness to give informed consent
You will not qualify if you...
- Patient under guardianship, trusteeship, or legal protection.
- Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proven effective contraception (according to the WHO definition) or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit).
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Trial Site Locations
Total: 10 locations
1
CHU Caen
Caen, France
Actively Recruiting
2
CHI Elbeuf
Elbeuf, France
Actively Recruiting
3
Groupe Hospitalier La Rochelle Ré-Aunis
La Rochelle, France
Actively Recruiting
4
CH Le Havre
Le Havre, France
Actively Recruiting
5
CHU Lille
Lille, France
Actively Recruiting
6
Hôpital Saint Philibert
Lomme, France
Actively Recruiting
7
CHU Rennes
Rennes, France
Actively Recruiting
8
Rouen University Hospital
Rouen, France, 76 031
Actively Recruiting
9
Clinique Saint Hilaire
Rouen, France
Actively Recruiting
10
CHU Sud Réunion
Saint-Pierre, France
Actively Recruiting
Research Team
C
Corentin Chaumont, MD
CONTACT
F
Frederic Anselme, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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