Atrial Fibrillation (AF)
Conditions
Keywords
Atrial Fibrillation, Ensite X Software, Atrial arrhythmia, Catheter ablation
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.
Interventions
PROCEDURECatheter 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
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single-procedure freedom from AF | From the catheter ablation date to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | A 7-day holter will be performed in the 6th and 12th months. |
| Safety | From the catheter ablation date to 12 months follow-up | 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 |
Countries
Taiwan
Outcome results
None listed