Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

— era-cryo  

Official title:

Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05492760
• Other study ID #: era-cryo
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2022
• Source: Shanghai 10th People's Hospital
• Contact: Yawei Xu, doctor
• Phone: 13916698181
• Email: xuyawei[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Device:
• cryoballoon ablation
Patients with AF will accept cryoballoon ablation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to atrial fibrillation recurrent	the time to atrial fibrillation recurrent	1year after the cryoballoon ablation