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 new approach to catheter ablation can help people with persistent atrial fibrillation feel better and reduce their heart rhythm problems compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Buddhist Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT05426603 on ClinicalTrials.gov |
What this trial studies
This 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 control group receiving only pulmonary vein isolation. The study aims to assess the recurrence of atrial arrhythmias and other procedural outcomes over time. Inclusion criteria focus on patients with symptomatic AF who have not responded to at least one antiarrhythmic medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with symptomatic persistent atrial fibrillation that is refractory or intolerant to antiarrhythmic medications.
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 lead to improved long-term outcomes for patients with persistent atrial fibrillation.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of similar approaches, indicating that this trial may provide valuable insights into the treatment of persistent atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 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
Hualien City
- Wen-Chin Tsai — Hualien City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chia-Hsin Chiang
- Email: qqsnoopy0223@gmail.com
- Phone: +886-2-28712121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.