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Safety and Appropriateness of Pacemakers with Closed Loop Stimulation in Patients with Sick Sinus Syndrome - A Study in Patients with a History of Atrial Fibrillation

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	sinus sinus syndrome
Date of first enrollment	27/01/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	To activate the CLS function.

Outcome(s)

Primary Outcome

The incidence of patient intolerance to CLS (referring to the discontinuation of CLS due to worsening subjective symptoms such as dyspnea, palpitations, fatigue, or discomfort) occurring from the activation of the CLS function until the end of the observation period (Day 180).

Secondary Outcome

1) The incidence and changes in subjective symptoms (dyspnea, palpitations, fatigue, and discomfort) from the activation of the CLS function until the end of the observation period (Day 180), compared to pre-implantation. 2) The total duration and longest duration of atrial high rate episode (AHRE) occurring from the activation of the CLS function until the end of the observation period (Day 180).

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who meet all of the following criteria will be included: (1) Patients who have undergone pacemaker implantation for sick sinus syndrome, have passed at least 30 days since implantation at the time of enrollment, and have a documented history of either clinical or subclinical atrial fibrillation, including diagnoses made before pacemaker implantation. (2) Patients aged 20 years or older at the time of enrollment. (3) Patients who have provided written informed consent to participate in this study.
Exclude criteria	Patients who meet any of the following criteria will be excluded: (1) Patients with a reduced left ventricular ejection fraction (less than 50%). (2) Patients diagnosed with decompensated heart failure. (3) Patients with prior experience or history of CLS function use. (4) Patients judged to be inappropriate for inclusion by the principal or sub-investigator.