A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -

A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study - - A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -(R and B trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022272

Enrollment

200

Registered

2016-05-11

Start date

2016-05-01

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

Atrial fibrillation

Interventions

Cryo ablation RF ablation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with paroxysmal atrial fibrillation 2)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study

Exclusion criteria

Exclusion criteria: 1)Patients who undergo the treatment other than pulmonary vein isolation, complicated with atrial flutter or paroxysmal supraventricular tachycardia 2)Patients with severe mitral regurgitation or mitral stenosis after pacemaker implantation 3)Hemodialysis patients 4)Patients who are judged inappropriate by the principal investigator

Design outcomes

Primary

Measure	Time frame
Change of outcome of MIBG before and after treatment	—

Secondary

Measure	Time frame
1) The change of heart rate variability by Holter electrocardiogram 2)The relation between the change of NGF-B and the index of sympathetic nerve activation 3) The change of hs CRP/PINP/PIIINP 4) The relation between the recurrence within one year and primary outcomes (index predicting recurrence) 5) The relation between the index of sympathetic nerve activation and primary outcomes (including the intraoperative evaluation) 6) Pulmonary vein stenosis on CT	—

Measure

Time frame

1) The change of heart rate variability by Holter electrocardiogram 2)The relation between the change of NGF-B and the index of sympathetic nerve activation 3) The change of hs CRP/PINP/PIIINP 4) The relation between the recurrence within one year and primary outcomes (index predicting recurrence) 5) The relation between the index of sympathetic nerve activation and primary outcomes (including the intraoperative evaluation) 6) Pulmonary vein stenosis on CT

—

Countries

Japan

Contacts

Public ContactMasato Kawasaki

Osaka General Medical Center Department of Cardiology

kenkyusien@gh.opho.jp06-6692-1201

Outcome results

None listed

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