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cloSed-loOp stimuLation sInus noDe dysfunctIon conducTion sYstem

Evaluation of Efficacy of Closed-Loop Stimulation in Sinus Node Dysfunction Patients Who Received Permanent Pacemaker Implantation with Conduction System Pacing

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010045
Enrollment
150
Registered
2024-12-13
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

None listed

Sponsors

Keimyung University Dongsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged from 20 to 90 years old 2) Patients with sinus who fall under the following among the “Payment Standards for Pacemaker Mounting Surgery 1. Sinus Dysfunction” announced by the Ministry of Health and Welfare's notification and have been implanted with a pacemaker within 1 month: A) If symptomatic bradycardia or symptomatic sinus pause has been proven in an awake state B) If the patient has symptomatic chronotropic incompetence C) If symptomatic bradycardia due to medication that needs to be administered because of medical condition has been proven in an awake state. D) If there is clinically relevant symptomatic bradycardia and the relationship between and symptom and bradycardia has not been proven, the heart rate is lower than 40/min at an awareness E) If significant SND disfunction is noticed or occurred during electrophysiology study with a patient who has been fainted(syncope) for an unknown reason 3) If the left ventricular ejection fraction is greater than 45% and the left ventricular end-diastolic diameter is less than 55 mm under echocardiogram. 4) Those who understood explanation describing the study method, and completed and submitted written informed consent.

Exclusion criteria

Exclusion criteria: ? Those with 2nd or 3rd degree atrioventricular block ? Patients with PR interval of more than 300 msec in 12-lead electrocardiogram prior to the procedure ? Patients with a life expectancy of less than 12 months ? Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
AF burden (AF or automatic mod switch percentage) displayed under pacemaker interrogation at the 3M, 9M and 15M after the study enrollment

Secondary

MeasureTime frame
The implantation success rate of LBBAP;final paced QRS duration on 12 lead ECG;complications related to the procedure;used type of LBBAP sheath

Countries

Korea, Republic of

Contacts

Public Contactjongmin Hwang

Keimyung University Dongsan Hospital

jinew326@naver.com+82-53-258-4628

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026