sinus sinus syndrome sinus sinus syndrome
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Nagoya City University Hospital