Evaluation of Recurrence Risk of Atrial Fibrillation Afte... | NCT05492760

Studies
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation

NCT05492760

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Aug 9, 2022Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

cryoballoon ablation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Estimated

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Jul 31, 2022

First Submission Date that Met QC Criteria

Aug 6, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2022

Last Update Posted Date

Aug 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ablation group			Device: cryoballoon ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cryoballoon ablation	Device	Patients with AF will accept cryoballoon ablation.	ablation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the time to atrial fibrillation recurrent	the time to atrial fibrillation recurrent	1year after the cryoballoon ablation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with paroxysmal AF and accept cryoballoon ablation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yawei Xu, doctor	Contact	13916698181		xuyawei@tongji.edu.cn

Overall Officials

Name	Affiliation	Role
Yawei Xu, doctor	Shanghai 10th People's Hospital	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided