Analyzing Electrograms in Patients with Persistent Atrial Fibrillation

A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

This study is testing if a more complete heart procedure can help people with persistent atrial fibrillation have fewer heart rhythm problems in the long run compared to a standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years to 90 Years
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (other gov)
• Locations: 1 site (Taipei)
• Trial ID: NCT05333952 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the long-term effectiveness of catheter ablation for persistent atrial fibrillation (AF) by utilizing advanced mapping techniques to modify atrial substrate. Participants will undergo pulmonary vein isolation followed by selective substrate ablation, with the aim of reducing the recurrence of atrial arrhythmias. The study compares outcomes between those receiving the full ablation approach and a control group receiving only pulmonary vein isolation. Key endpoints include the long-term recurrence of arrhythmias and procedural safety.

Who should consider this trial

Good fit: Ideal candidates include symptomatic patients with persistent or permanent atrial fibrillation who are refractory or intolerant to at least one antiarrhythmic medication.

Not a fit: Patients with atrial or ventricular thrombus, renal insufficiency, or those who do not require atrial substrate modification may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial fibrillation in patients who have not responded to standard treatments.

How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of similar ablation techniques, indicating that this approach may provide new insights into treatment strategies.

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 persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
4. 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) or previous catheter ablation in the LA or MAZE procedure.
6. Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
7. Patients with age less than 20 years old or greater than 90 years old regardless of gender.

Where this trial is running

Taipei

• Taipei General Veterans Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Yenn-Jiang Lin, MD, PhD — Director of Cardiology Division of Taipei Veterans General Hospital
• Study coordinator: Chia-Hsin Chiang

Conditions: Atrial Fibrillation, Persistent, Catheter ablation, Mapping technique, Substrate mapping, Non-linear electrogram morphology analysis