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

NCT06632925 | Active Not Recruiting

• 1 other identifier: 2024-03-001A
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Ensite X Software; Atrial arrhythmia; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• Single-procedure freedom from AF

  The study's primary endpoint was single-procedure freedom from AF after a blanking period based on a single procedure. After discharge, the patients were followed up (two weeks after the catheter ablation, then every 3 months) at our cardiology clinic or with the referring physician. During each follow-up, 24-hour Holter monitoring, or cardiac event recording was performed for a week. A 7-day holter will be performed in the 6th and 12th months. Recurrence was defined as any atrial arrhythmia recurrence, including AF and atrial tachycardia, and was defined as an episode lasting \>1 minute and confirmed by ECGs months after the ablation.

  From the catheter ablation date to 12 months

Secondary Outcomes (3)

• Non-inducibility of AF or AFL

  During catheter ablation procedure

• Any recurrence of all atrial arrhythmias after the first procedure

  In the 6th and 12th months after catheter ablation.

• Safety

  From the catheter ablation date to 12 months follow-up

Interventions

Catheter ablation PROCEDURE

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Criteria for inclusion (same as current inclusion criteria for catheter ablation of AF): 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. Criteria for exclusion (same as current inclusion criteria for catheter ablation of AF): 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.

You may qualify if:

• Patents who sign the informed consent forms, and allow to be followed.
• Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
• Patients with age equal or greater than 20 years old regardless of gender.

You may not qualify if:

• The presence of a atrial or ventricular thrombus.
• Patients who are allergic to or unsuitable for use with the contrast media.
• Pregnant patients or patients who are unavailable to receive X-ray.
• Patients with renal insufficiency.
• Patients had autonomic nervous system disorder (e.g. respiratory apnea)
• Patients with age less than 20 years old or greater than 80 years old regardless of gender.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Veterans General Hospital, Department of Heart Rhythm Center and Cardiovascular Center. Associate Professor, School of Medicine, National Yang-Ming Chiao Tung University.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 9, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

TW (1)