Clinical trial NCT06632925: Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study
Official title: Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Ensite X Software
Atrial arrhythmia
Catheter ablation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Single-procedure freedom from AF
timeFrame: From the catheter ablation date to 12 months
Secondary outcomes:
measure: Non-inducibility of AF or AFL
timeFrame: During catheter ablation procedure
measure: Any recurrence of all atrial arrhythmias after the first procedure
timeFrame: In the 6th and 12th months after catheter ablation.
measure: Safety
timeFrame: From the catheter ablation date to 12 months follow-up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: