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Safety and Appropriateness of Pacemakers with Closed Loop Stimulation in Patients with Sick Sinus Syndrome

Safety and Appropriateness of Pacemakers with Closed Loop Stimulation in Patients with Sick Sinus Syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250075
Enrollment
20
Registered
2025-08-12
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sinus sinus syndrome sinus sinus syndrome

Interventions

Sponsors

GOTO TOSHIHIKO
Lead Sponsor

Eligibility

Sex/Gender
All

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, with no prior diagnosis of clinical atrial fibrillation. (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: (1) Patients with a reduced left ventricular ejection fraction (less than 50%). (2) Patients diagnosed with decompensated heart failure. (3) Patients with a history of CLS function use. (4) Patients deemed inappropriate by the principal/sub investigator.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Public ContactTOSHIHIKO GOTO

Nagoya City University Hospital

t-goto@med.nagoya-cu.ac.jp+81-52-853-8221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026