What is this study trying to find out about conduction system pacing?

This study aims to evaluate the long-term electrical, heart function, and clinical outcomes of conduction system pacing, a device-based treatment for heart rhythm conditions. It looks at how well the pacing maintains normal heart activation and its effects on heart function over two years. The research is sponsored by University Hospital, Rouen.

Who may be eligible for this conduction system pacing clinical trial?

Adults aged 18 years or older who have had a conduction system pacing attempt and are able to give informed consent may be eligible. Both men and women can participate, but pregnant or breastfeeding women are excluded. Patients under legal guardianship are also not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this conduction system pacing clinical trial?

Study-related care, including device checks and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Age: 18Years +

All Genders

Healthy Volunteers

ID06088927

Long-term Outcomes of Conduction System Pacing a National Multicenter Observational Study - NORMANDHIS STIMUHIS

Led by University Hospital, Rouen · Updated on 2023-10-18

2500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing CSP, which includes His Bundle Pacing or Left Bundle Branch Area Pacing. This observational study addresses the limited data currently available on the long-term results and benefits of CSP, especially focusing on the maintenance of physiological ventricular activation and conduction system capture over time. The study aims to provide reliable data on the preservation of CSP during a two-year follow-up period. Participants who have undergone a conduction system pacing attempt will be followed prospectively. Electrical data such as pacing thresholds, impedance, and R wave sensing will be collected during routine pacemaker check-ups to assess threshold stability. Echocardiographic evaluations will monitor changes in left ventricular ejection fraction LVEF and ventricular synchrony. Clinical data including the incidence of atrial fibrillation, heart failure hospitalizations, and NYHA stage will also be gathered to provide a comprehensive view of patient outcomes. Participants will undergo systematic follow-up visits over 24 months to record electrical parameters, heart function via echocardiography, and clinical status. The main outcome measured is freedom from major adverse events at 24 months. Secondary measures include LVEF, atrial fibrillation incidence, heart failure hospitalizations, conduction system pacing thresholds, paced QRS width, and ventricular dyssynchrony parameters. This long-term observation will help clarify the benefits and stability of CSP in a real-world setting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Patient who had undergone conduction system pacing attempt
Age > 18 years old
Capacity to understand the nature of the study, legal ability and willingness to give informed consent

You will not qualify if you...

Patient under guardianship, trusteeship, or legal protection
Pregnant woman or breastfeeding
Lack of proven effective contraception or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before inclusion)

Research Team

Corentin Chaumont, MD

Frederic Anselme, MD, PhD

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