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

NCT04833985 | Completed

• 1 other identifier: TEE vs.ICE vs.fluoroscopy only
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• injected contrast media

  milliliter

  in the procedure

• fluoroscopy time were recorded

  mGy

  in the procedure

Secondary Outcomes (6)

• the time from femoral vein puncture to transseptal puncture to closure were recorded

  in the procedure

• The size of the LAA

  in the procedure

• the size of the selected umbrella in operation

  in the procedure

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

  before operation and 3 months after operation

• new pericardial effusion were detected

  3 months after operation

Study Arms (3)

transesophageal echocardiography guidance

EXPERIMENTAL

Procedure: LAAC combined with radiofrequency ablation

intracardiac echocardiography guidance

EXPERIMENTAL

Procedure: LAAC combined with radiofrequency ablation

fluoroscopy only guidance

EXPERIMENTAL

Procedure: LAAC combined with radiofrequency ablation

Interventions

LAAC combined with radiofrequency ablation PROCEDURE

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

fluoroscopy only guidance; intracardiac echocardiography guidance; transesophageal echocardiography guidance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• xieruiqin: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of cardiology department

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 6, 2021
• Study Start: July 13, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: May 5, 2022

Record last verified: 2020-07

Locations

CN (1)