Cycle-length mapping with OPTRELL for non-paroxysmal atrial fibrillation

A Prospective Study on the Cycle-Length Mapping Using the OPTRELL™ Mapping Catheter in Patients With Non-paroxysmal Atrial Fibrillation

This will try an ultra-high-density OPTRELL mapping catheter to map electrical cycle length and voltage in people with persistent or permanent atrial fibrillation to better target ablation.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (Government)
• Locations: 1 site (Taipei, Outside US)
• Trial ID: NCT06960252 on ClinicalTrials.gov

What this trial studies

The study will use the OPTRELL ultra-high-density mapping catheter to obtain unipolar and bipolar voltage maps in sinus rhythm and cycle-length maps during atrial fibrillation in patients with non-paroxysmal AF. Investigators will compare mapped cycle-length drivers and areas of low voltage consistent with interstitial fibrosis to better characterize the atrial substrate. The protocol builds on prior multicenter CLM work showing benefit from targeted driver ablation and applies a new mapping catheter to refine substrate identification. The observational design focuses on mapping and characterization to inform potential targeted ablation strategies rather than randomizing treatments.

Who should consider this trial

Good fit: Adults aged 20 or older with symptomatic persistent or permanent AF who are refractory or intolerant to at least one Class I or III antiarrhythmic medication and can provide informed consent are ideal candidates.

Not a fit: Patients with an atrial or ventricular thrombus, severe renal insufficiency or dialysis, contrast allergy, pregnancy, inability to undergo X-ray, or those with paroxysmal AF are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could enable more precise, patient-tailored ablation and reduce AF recurrence after the procedure.

How similar studies have performed: Previous multicenter CLM work between Taipei Veterans General Hospital and IRCCS San Donato showed targeted CLM driver-ablation improved arrhythmia-free outcomes, while applying the OPTRELL catheter in this setting represents a newer application.

Eligibility 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). Persistent AF is defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted longer than 12 months will be defined as long standing persistent AF.
4. Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria:

1. The presence of an 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 severe renal insufficiency. (Glomerular Filtration Rate \[GFR\] \< 15 mg/dl or under dialysis)
5. Patients had autonomic nervous system disorder (e.g. respiratory apnea).
6. Patients with age less than 20 years old or greater than 90 years old regardless of gender.
7. Contraindications to anticoagulation.

Where this trial is running

Taipei, Outside US

• Taipei Veterans General Hospital — Taipei, Outside US, Taiwan (Recruiting)

Study contacts

• Study coordinator: Ting-Yung Chang, M.D.

Conditions Atrial Fibrillation