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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP), which includes His Bundle Pacing or Left Bundle Branch Area Pacing. This observational study addresses the limited data currently available on the long-term results and benefits of CSP, especially focusing on the maintenance of physiological ventricular activation and conduction system capture over time. The study aims to provide reliable data on the preservation of CSP during a two-year follow-up period. Participants who have undergone a conduction system pacing attempt will be followed prospectively. Electrical data such as pacing thresholds, impedance, and R wave sensing will be collected during routine pacemaker check-ups to assess threshold stability. Echocardiographic evaluations will monitor changes in left ventricular ejection fraction (LVEF) and ventricular synchrony. Clinical data including the incidence of atrial fibrillation, heart failure hospitalizations, and NYHA stage will also be gathered to provide a comprehensive view of patient outcomes. Participants will undergo systematic follow-up visits over 24 months to record electrical parameters, heart function via echocardiography, and clinical status. The main outcome measured is freedom from major adverse events at 24 months. Secondary measures include LVEF, atrial fibrillation incidence, heart failure hospitalizations, conduction system pacing thresholds, paced QRS width, and ventricular dyssynchrony parameters. This long-term observation will help clarify the benefits and stability of CSP in a real-world setting.
CONDITIONS
Brief 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 years old
- 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 or breastfeeding
- Lack of proven effective contraception or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before inclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from hospital
Participants undergo conduction system pacing (His Bundle Pacing or Left Bundle Branch Area Pacing).
1 procedure visit and 1 pre-discharge visit
Duration - Up to 24 months
Participants are followed for up to 24 months to monitor outcomes including device performance and heart function.
Regular follow-up visits over 24 months
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
F
Frederic Anselme, MD, PhD
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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