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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05492760
Other study ID # era-cryo
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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