NCT05492760

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

July 31, 2022

Last Update Submit

August 6, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • the time to atrial fibrillation recurrent

    the time to atrial fibrillation recurrent

    1year after the cryoballoon ablation

Study Arms (1)

ablation group

Device: cryoballoon ablation

Interventions

cryoballoon ablationDEVICE

Patients with AF will accept cryoballoon ablation.

ablation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with paroxysmal AF and accept cryoballoon ablation.

You may qualify if:

  • Patients with paroxysmal AF and accept cryoballoon ablation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yawei Xu, doctor

    Shanghai 10th People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Yawei Xu, doctor

CONTACT

13916698181xuyawei@tongji.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 9, 2022

Study Start

August 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share