Evaluating long-term outcomes of conduction system pacing
Official title: Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Run by University Hospital, Rouen · NCT06088927 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 10 sites (Caen and 9 other locations) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | October 18, 2023 |
| Trial ID | NCT06088927 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who have undergone a conduction system pacing attempt.
✕Probably not a fit
Patients who are under guardianship, pregnant, breastfeeding, or lack effective contraception may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 4 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Conduction system pacing vs biventricular pacing for CRT
This study tests whether pacing the heart’s conduction system (HIS or left bundle) during CRT works better than standard biventricular pacing for people with heart failure.
-
Comparing two pacemaker pacing methods for AV block
This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.
-
Pacing decisions guided by risk for pacing-induced heart muscle weakness
This study tests a risk score to predict pacing-induced cardiomyopathy in adults getting heart rhythm devices, to tailor pacing choices.
-
Left bundle branch area pacing with Tendril STS or UltiPace leads
This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.
-
Simplifying conduction system pacemaker implantation
This project will try new imaging and electrical mapping methods to make conduction system pacemakers easier to implant and interpret for adults who need ventricular pacing.
-
Comparing two pacing methods for heart failure patients
This study is testing whether a new pacing method called conduction system pacing can help heart failure patients just as much as the standard biventricular pacing to improve their heart function.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.