Prospective Cohort Study of the Risk of Recurrent Atrial... | NCT05638841

Studies
Prospective Cohort Study of the Risk of Recurrent Atrial Fibrillation After Radiofrequency Ablation

NCT05638841

Sponsor

Peking University Third Hospital

Status

Recruiting

Last Update Posted

Feb 21, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

After radiofrequency ablation of atrial fibrillation

Countries

China

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 28, 2022

First Submission Date that Met QC Criteria

Nov 28, 2022

First Posted Date

Dec 6, 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

Feb 19, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In this study, the continuous inclusion of atrial fibrillation patients treated by catheter ablation in the Department of Cardiology, Peking University Third Hospital, through the collection of clinical data and outpatient follow-up, to explore the risk factors of atrial fibrillation recurrence after catheter ablation and the influencing factors of major clinical events in atrial fibrillation patients, and further guide the management mode of atrial fibrillation patients.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atrial fibrillation		After radiofrequency ablation of patients with atrial fibrillation	Other: After radiofrequency ablation of atrial fibrillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
After radiofrequency ablation of atrial fibrillation	Other	This study imposed an intervention. Clinical data were obtained by telephone or outpatient follow-up.	atrial fibrillation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compound cardiovascular event	Stroke, hemorrhage, re-hospitalization for atrial fibrillation and heart failure, and all-cause death	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) Age > 18
2) ECG or holter electrocardiogram confirmed atrial fibrillation

Exclusion Criteria:

1) Hematological diseases, autoimmune diseases and malignant tumors
2) Immobility caused by hemiplegia or severe trauma
3) The expected survival time is less than 2 years
4) Poor compliance and high risk of expected loss of follow-up
5) Disorders of consciousness or Alzheimer's disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In this study, atrial fibrillation patients who meet the inclusion criteria and those who do not meet the exclusion criteria were admitted to the Department of Cardiology of Peking University Third Hospital after catheter ablation from December 31, 2022 to December 31, 2023

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanguang Li, Doctor	Contact	+8613693327068		liyanguangsuper@163.com
Pengxin Xie, master	Contact	+8618810793282		xiepengxin2014@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking-University-Third-Hospital	Recruiting	Beijing			China

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