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

Conduction System Pacing Clinical Trial

— STIMU'HIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088927
• Other study ID #: 2020/0417/OB
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 31, 2028

Study information

• Verified date: March 2023
• Source: University Hospital, Rouen
• Contact: Corentin Chaumont, MD
• Phone: + 33637182032
• Email: corentin.chaumont[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Conduction System Pacing

Intervention

Device:
• Conduction system pacing
Conduction system pacing (His Bundle Pacing or Left Bundle Branch Area Pacing)

Locations

Country	Name	City	State
France	CHU Caen	Caen
France	CHI Elbeuf	Elbeuf
France	Groupe Hospitalier La Rochelle Ré-Aunis	La Rochelle
France	CH Le Havre	Le Havre
France	CHU Lille	Lille
France	Hôpital Saint Philibert	Lomme
France	CHU Rennes	Rennes
France	Clinique Saint Hilaire	Rouen
France	Rouen University Hospital	Rouen
France	CHU Sud Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse events	Major adverse events are defined as follow : Lead revision (including infection and pacing threshold increase); Lead dislodgment; Loss of conduction system pacing (i.e. loss of His Bundle Pacing or Left Bundle Branch area pacing according to standard definitions); Heart Failure Hospitalization; Upgrade to BiVentricular pacing; All cause mortality	24 months
Secondary	LVEF (%)		24 months
Secondary	AF incidence		24 months
Secondary	Heart Failure Hospitalization Incidence		24 months
Secondary	CSP Threshold during pacemaker check (Volt @ ms)		24 months
Secondary	Paced QRS width		24 months
Secondary	Interventricular dyssynchrony parameters	Aortic pre-ejection time (ms) - Pulmonary pre-ejection time (ms) (echocardiography)	pre-discharged
Secondary	Intraventricular dyssynchrony parameters	Difference between the first and last left ventricular systolic peak using 2D speckle tracking (echocardiography)	pre-discharged