Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study

NCT ID: NCT06632925

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-06-30

Brief Summary

A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software, as a prospective study.

Detailed Description

This study was designed to determine the efficacy of substrate ablation using HD Grid Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification in AF patients who required substrate modification. This study is a prospective, single-center in which patients with AF who will receive catheter ablation.

The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter. The end-point of ablation is non-inducible of AF or AFL. The procedure time, fluoroscopic time, procedural termination rate, and recurrence of atrial arrhythmia would be collected. If the flutter or the non-PV triggers were inducible, isthmus ablation and the non-PV trigger ablation will be performed accordingly.

Conditions

Atrial Fibrillation (AF)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Catheter ablation

The catheter ablation strategy is the same as the current treatment approach in patients with AF, according to the consensus of catheter ablation of AF. All procedures will be performed under local sedation or general anesthesia depending on the operator, and each patient will undergo an electrophysiological study and substrate mapping in the fasting state with adequate pre-ablation anticoagulation and transesophageal echocardiography to rule out LA thrombus. All antiarrhythmic drugs except amiodarone will be discontinued for at least 5 half-lives before the procedure.

Step I: Substrate mapping before ablation, Step II: Pulmonary vein isolation (PVI), Step III: Post-ablation mapping in SR immediately after ablation, Step IV: Inducibility after ablation, Step V: Remmaping 30 minutes after ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patents who sign the informed consent forms, and allow to be followed.

2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.

3. Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria

1. The presence of a atrial or ventricular thrombus.

2. Patients who are allergic to or unsuitable for use with the contrast media.

3. Pregnant patients or patients who are unavailable to receive X-ray.

4. Patients with renal insufficiency.

5. Patients had autonomic nervous system disorder (e.g. respiratory apnea)

6. Patients with age less than 20 years old or greater than 80 years old regardless of gender.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chin-Yu Lin

Taipei Veterans General Hospital, Department of Heart Rhythm Center and Cardiovascular Center. Associate Professor, School of Medicine, National Yang-Ming Chiao Tung University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2024-03-001A

Identifier Type: -

Identifier Source: org_study_id