Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation

• Conditions: Atrial Fibrillation
• Interventions: Device: cryoballoon ablation

• Registration Number: NCT05492760
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-31
• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-06
• Last Update Submitted: 2022-08-06
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients with paroxysmal AF and accept cryoballoon ablation.

Exclusion Criteria

• left atrium (LA) diameter (anterior-to-posterior)>55mm on transthoracic echocardiography (TTE)
• the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)
• uncorrected heart failure (NYHA class III or IV),
• concomitant moderate or severe valvular heart disease or bioprosthetic valve,
• malignancy necessitating chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ablation group	cryoballoon ablation	-

Primary Outcome Measures

Name	Time	Method
the time to atrial fibrillation recurrent	1year after the cryoballoon ablation	the time to atrial fibrillation recurrent