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Search / Trial NCT06088927

Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

Launched by UNIVERSITY HOSPITAL, ROUEN · Oct 12, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

The NORMAND'HIS / STIMU'HIS trial is a study that looks at the long-term effects of a treatment called conduction system pacing (CSP), which is used to help patients with heart rhythm issues. The researchers want to understand how well CSP works over time, particularly its impact on heart function and the risk of complications like atrial fibrillation, a type of irregular heartbeat. This study is important because there hasn’t been enough information about the long-term results of CSP compared to traditional pacing methods.

To participate in this trial, you need to be over 18 years old and have already undergone a CSP procedure. You should also be able to understand the study and agree to participate. If you join, you can expect regular check-ups to assess your heart's electrical activity and overall health for at least two years. The study will closely monitor your heart's function using ultrasound and track any hospital visits due to heart issues. This research aims to provide valuable insights that could improve the care and outcomes for patients with heart rhythm problems in the future.

Gender

ALL

Eligibility 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).

About University Hospital, Rouen

The University Hospital of Rouen is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent academic hospital, it integrates cutting-edge medical education with patient care, fostering an environment where clinical research is paramount. With a multidisciplinary team of expert clinicians and researchers, the hospital focuses on a wide range of therapeutic areas, aiming to improve patient outcomes and contribute to the global medical community. The University Hospital of Rouen is committed to ethical standards and rigorous scientific methodologies, ensuring the highest quality of care and research integrity in all its clinical trials.

Locations

Rouen, , France

Caen, , France

Rennes, , France

Lille, , France

Le Havre, , France

Lomme, , France

Elbeuf, , France

La Rochelle, , France

Rouen, , France

Saint Pierre, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported