Recruiting

The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Arrhythmias, Cardiac+4

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2021
See protocol details

Summary

Principal SponsorShanghai 10th People's Hospital
Study ContactDongdong ZhaoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 10, 2021

Actual date on which the first participant was enrolled.

1. Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes. 2. Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are: i. Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. 3. Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional. For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath. 4. Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.

Official TitleThe Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
NCT05106270
Principal SponsorShanghai 10th People's Hospital
Study ContactDongdong ZhaoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesHeart FailurePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; * Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. * Capable of understanding and signing the informed consent form. * Aged over 18 years. Exclusion Criteria: * Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication; * Concomitant arrhythmia including atrial flutter, ventricular tachycardia; * A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation; * A previous history of cardiac surgery including any valvular replacement, septal repair; * A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation; * A history of congenital heart disease; * A previous history of atrioventricular node ablation; * A history of lobectomy due to any medical condition; * Complicated by other diseases with life expectation \<1 year; * Women with childbearing potential; * Participated in other interventional clinical trials that might affect prognosis; * Unable to understand or give informed consent form.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, ChinaOpen Department of Cardiology, Shanghai Tenth People's Hospital in Google Maps
Recruiting
One Study Center