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NCT Number: NCT06632925

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Single-procedure freedom from AF

    Time frame: 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 outcomes

  1. Non-inducibility of AF or AFL

    Time frame: During catheter ablation procedure

  2. Any recurrence of all atrial arrhythmias after the first procedure

    Time frame: In the 6th and 12th months after catheter ablation.

    A 7-day holter will be performed in the 6th and 12th months.

  3. Safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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