An observational study in Atrial Fibrillation (AF), sponsored by Taipei Veterans General Hospital, Taiwan. Active, not recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Taipei Veterans General Hospital, Taiwan · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 80 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Criteria for inclusion (same as current inclusion criteria for catheter ablation of
AF):
Criteria for exclusion (same as current inclusion criteria for catheter ablation of
AF):
Exclusion Criteria:
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
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.
Time frame: From the catheter ablation date to 12 months
Non-inducibility of AF or AFL
Time frame: During catheter ablation procedure
Any recurrence of all atrial arrhythmias after the first procedure
A 7-day holter will be performed in the 6th and 12th months.
Time frame: In the 6th and 12th months after catheter ablation.
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
Time frame: From the catheter ablation date to 12 months follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan