Catheter Ablation for Atrial Fibrillation After Percutaneous Mitral Valve Repair

JRCT ID: jRCTs042200051

Registered date:19/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 19/10/2020
• Target sample size: 20
• Study type: Interventional

Intervention(s)

arm Catheter Ablation: cryoballoon ablation for atrial fibrillation.
arm Drug: Drugs for atrial fbirillation will be continued.

Outcome(s)

• Primary Outcome: BNP, NT-proBNP
• Secondary Outcome: All-cause death, Heart failure hospitalization, stroke, major bleeding

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1)Patients undergoing percutaneous mitral valve repair (PMVR) for mitral regurgitation
2)Patients with paroxysmal or persistent atrial fibrillation. Diagnosis of atrial fibrillation is performed with a 12-lead electrocardiogram, a Holter electrocardiogram, an implantable device (ICD / CRT-D / loop recorder), or a portable electrocardiograph. Case registration is limited to cases where atrial fibrillation has been recorded within one year retroactively from study registration.
3)Age at the time of PMVR treatment is 20 years old or older and less than 90 years old

Exclude criteria

1)Patients undergoing percutaneous mitral valve repair (PMVR) for mitral regurgitation
2)Patients with paroxysmal atrial fibrillation (2 or more events lasting 30 seconds or more). Even if atrial fibrillation persists for 7 days or more, it is registered as paroxysmal atrial fibrillation when it becomes sinus rhythm by drug or cardioversion and then becomes paroxysmal atrial fibrillation. Diagnosis of atrial fibrillation is performed with a 12-lead electrocardiogram, a Holter electrocardiogram, an implantable device (ICD / CRT-D / loop recorder), or a portable electrocardiograph. Case registration is limited to cases where atrial fibrillation has been recorded within one year retroactively from study registration.
3)Age at the time of PMVR treatment is 20 years old or older and less than 90 years old

Related Information

• Primary Sponsor: Kinugawa Koichiro
• Secondary Sponsor: Kataoka Naoya
• Source(s) of Monetary Support: Medtronic Japan Co., Ltd.