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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Catheter ablation

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any recurrence of all atrial arrhythmias after the first procedure	A 7-day holter will be performed in the 6th and 12th months.	In the 6th and 12th months after catheter ablation.
Non-inducibility of AF or AFL		During catheter ablation procedure
Safety	This outcome measure will assess the procedural time, radiation exposure time, and the incidence of major complications, including cardiac tamponade, peripheral aneurysm, cerebral infarction, and shock	From the catheter ablation date to 12 months follow-up

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter ablation; Atrial arrhythmia; Ensite X Software
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2024-03-001A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes