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A Multicenter Prospective Study Evaluating Pacemaker Implantation and Catheter Ablation for Comprehensive Outcomes in Tachycardia-Bradycardia Syndrome

A Multicenter Prospective Study Evaluating Pacemaker Implantation and Catheter Ablation for Comprehensive Outcomes in Tachycardia-Bradycardia Syndrome - EPIC-TBS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051672
Enrollment
250
Registered
2023-09-20
Start date
2023-10-01
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

Tachycardia-bradycardia syndrome

Interventions

None listed

Sponsors

Juntendo University Graduate School of Medicine, Department of Cardiovascular Biology and Medicine, Shunsuke Kuroda
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following conditions will be included in this study: 1. Either of the following two criteria will be observed at the cessation of atrial ectopic tachycardia, atrial fibrillation, atrial flutter, or atrial tachycardia (supraventricular tachycardia) : 1-1. The sinus pause time after the cessation of supraventricular tachycardia is more than 5 seconds. 1-2. The sinus pause time after the cessation of supraventricular tachycardia is more than 3 seconds, and it causes by the sinus pause or it is plausible that the pauses cause symptoms related to tachycardia-bradycardia syndrome within the last three. 2. They are scheduled for either catheter ablation or pacemaker implantation therapy within the next three months. 3. Written consent for participation in the study can be obtained from the individual.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria from 1 to 7 will be excluded from this study: 1. Patients who have previously received any of the following treatments: Catheter ablation for atrial fibrillation, maze surgery, permanent pacemaker implantation, mechanical heart valve replacement surgery. ] 2. Patients with a left ventricular ejection fraction less than 40% 3. Patients exhibiting complete atrioventricular block, advanced atrioventricular block, or complete left bundle branch block 4. Patients with a disease prognosis estimated to be less than one year 5. Patients for whom catheter ablation or permanent pacemaker procedures are considered difficult due to anatomical reasons from previous medical history 6. Cases where responses to the Quality of Life (QoL) questionnaire are difficult due to dementia or similar conditions 7. Other patients whom the research leader determines to be inappropriate as study subjects.

Design outcomes

Primary

MeasureTime frame
Change in quality of life assessment scale from before treatment to 6 months and 12 months after the initial pacemaker therapy or catheter ablation therapy, diagnosed as tachy-brady syndrome. This study will utilize either the AFEQT, the Short Form-12, or the EQ-5D-5L as the assessment tools for quality of life.

Secondary

MeasureTime frame
Complications during pacemaker or ablation therapy. Adverse events within 24 months after treatment, such as: Mortality, stroke, systemic embolism, major bleeding events, hospitalization for heart failure, syncope, pacemaker lead infection or extraction, or catheter ablation after the initial procedures.

Countries

Japan

Contacts

Public ContactShunsuke Kuroda

Juntendo University Graduate School of Medicine Department of Cardiovascular Biology and Medicine

s.kuroda.qm@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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