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Completed

NCT Number: NCT04833985

Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion

A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into 3 groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively (allocation ratio 1:1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE and fluoroscopy only were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack [TIA]). The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation. The average follow-up time is 3 months.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2 and HAS-BLED score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion criteria

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Treatment and study plan

LAAC combined with radiofrequency ablation

Procedure

Each patient received the same group of patients with simple radiofrequency ablation and LAAC

Primary outcomes

  1. injected contrast media

    Time frame: in the procedure

    milliliter

  2. fluoroscopy time were recorded

    Time frame: in the procedure

    mGy

Secondary outcomes

  1. the time from femoral vein puncture to transseptal puncture to closure were recorded

    Time frame: in the procedure

    second

  2. The size of the LAA

    Time frame: in the procedure

    millimeter

  3. the size of the selected umbrella in operation

    Time frame: in the procedure

    millimeter

  4. residual shunt and DRT after transcatheter closure of left atrial appendage detected

    Time frame: before operation and 3 months after operation

    Transesophageal echocardiography

  5. new pericardial effusion were detected

    Time frame: 3 months after operation

    Transthoracic echocardiography

  6. pericardial tamponade were detected

    Time frame: 3 months after operation

    Transthoracic echocardiography

Sponsors and collaborators

Lead sponsor

xieruiqin

Other

Registry information

Official study title

Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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