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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05492760
Collaborator
(none)
600
Enrollment
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cryoballoon ablation

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
ablation group

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

Outcome Measures

Primary Outcome Measures

  1. the time to atrial fibrillation recurrent [1year after the cryoballoon ablation]

    the time to atrial fibrillation recurrent

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

  • Study Director: Yawei Xu, doctor, Shanghai 10th People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ya-Wei Xu, professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05492760
Other Study ID Numbers:
  • era-cryo
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence

Study Results

No Results Posted as of Aug 9, 2022