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Treatment of tachycardia-bradycardia syndrome using radiofrequency catheter ablation of paroxysmal atrial fibrillation versus permanent pacemaker implantation: prospective, randomized trial

Comparison catheter ablation versus permanent pacemaker implantation in patients with tachycardia-bradycardia syndrome: prospective, randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000155
Enrollment
88
Registered
2011-07-28
Start date
2011-03-02
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Procedure/Surgery : The AF catheter ablation group underwent the curative catheter ablation procedures for paroxysmal AF by pulmonary vein isolation. Another group received the implantation of permane

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Documented prolonged sinus pauses on termination of AF ranging from 3 to 9 seconds 2. Symptoms of syncope or presyncope 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Left ventricular ejection fraction < 40% 2. prior history of ablation of atrial fibrillation 3. thrombi in Left atrium or Left atrial appendage 4. New York Heart Association class III or IV 5. prior acute myocardial infarction or coronary artery bypass grafting within 6 months 6. prior percutaneous coronary intervention within 1 year 7. Severe valvular disease 8. Life expectancy of less than one year 9. Contraindication of anticoagulants 10. Pregnant women or women planning pregnancy(The urine hCG test is usually performed in women of reproductive age)

Design outcomes

Primary

MeasureTime frame
all-cause hospitalization and syncope

Secondary

MeasureTime frame
all-cause death;atrial fibrillation burden by 24-hour ambulatory ECG monitoring;Minimum heart rate, Maximum pause, number of sinus pause > 3 seconds by 24-hour ambulatory ECG monitoring;LA size on transthoracic echocardiography ;treadmil test

Countries

Korea, Republic of

Contacts

Public ContactKi Won Hwang

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 6, 2026