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NCT06088927: STIMU'HIS
Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
trial testing Conduction system pacing in Conduction System Pacing in 2,500 participants. Currently enrolling.
31 March 2028
Quick facts
| Lead sponsor | University Hospital, Rouen |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 2,500 |
| Start date | 1 March 2023 |
| Primary completion | 31 March 2028 |
| Estimated completion | 31 March 2028 |
| Sites | 10 locations across France |
Drugs / interventions tested
- Conduction system pacing
Conditions studied
- Conduction System Pacing — all drugs for Conduction System Pacing →
Sponsor
University Hospital, Rouen
Who can join
18 and older, any sex, with Conduction System Pacing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06088927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Conduction system pacing
Trials testing the same drug.
- NCT07276490 — Central Haemodynamics and Pacing for AV Block · NA · recruiting
- NCT07430553 — Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure · NA · recruiting
- NCT06241651 — CSP Versus BiVP for Heart Failure Patients with RVP Upgraded to Cardiac Resynchronization Therapy · NA · recruiting
- NCT06197503 — Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI · NA · recruiting
- NCT05572736 — Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure · NA · completed
Other recruiting trials for Conduction System Pacing
Currently open trials in the same condition.
- NCT07276139 — PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD · active not recruiting
- NCT07276490 — Central Haemodynamics and Pacing for AV Block · NA · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
- NCT06488989 — Left Bundle Branch Area Pacing in Patients With Heart Failure · NA · active not recruiting
- NCT07464041 — Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fractio · NA · recruiting
Other University Hospital, Rouen trials
Trials by the same sponsor.
- NCT07441564 — Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Jux · NA · not yet recruiting
- NCT07535944 — Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors · not yet recruiting
- NCT07464184 — Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension · NA · not yet recruiting
- NCT07359885 — Prediction of Postoperative Pulmonary Complications in Thoracic Surgery · not yet recruiting
- NCT07247500 — Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP) · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06088927 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Rouen
- Last refreshed: 18 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06088927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing