Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation (era-cryo)

Tongji University

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Device: cryoballoon ablation

Study type: Observational

Funder types: Other

Identifiers

NCT05492760

era-cryo

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

ablation group

Treatment:

Device: cryoballoon ablation