Evaluating long-term outcomes of conduction system pacing
Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
This study is testing how well conduction system pacing works over two years for people with heart issues by looking at their heart function and any episodes of atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 10 sites (Caen and 9 other locations) |
| Trial ID | NCT06088927 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter registry aims to assess the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). The study will collect data on pacing thresholds, impedance, and R wave sensing during follow-up visits to evaluate the stability of CSP over a two-year period. Additionally, it will monitor the incidence of atrial fibrillation episodes to provide new insights into the long-term benefits of this pacing technique. The study addresses a gap in the literature regarding the long-term results of CSP.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have undergone a conduction system pacing attempt.
Not a fit: Patients who are under guardianship, pregnant, breastfeeding, or lack effective contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of conduction system pacing for patients with conduction disorders.
How similar studies have performed: While there is limited data on long-term outcomes of conduction system pacing, this study is designed to fill a significant gap in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
Where this trial is running
Caen and 9 other locations
- CHU Caen — Caen, France (Recruiting)
- CHI Elbeuf — Elbeuf, France (Recruiting)
- Groupe Hospitalier La Rochelle Ré-Aunis — La Rochelle, France (Recruiting)
- CH Le Havre — Le Havre, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Hôpital Saint Philibert — Lomme, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- Rouen University Hospital — Rouen, France (Recruiting)
- Clinique Saint Hilaire — Rouen, France (Recruiting)
- CHU Sud Réunion — Saint-Pierre, France (Recruiting)
Study contacts
- Study coordinator: Corentin Chaumont, MD
- Email: corentin.chaumont@chu-rouen.fr
- Phone: + 33637182032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.