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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Taipei Veterans General Hospital
  Taipei, Outside US, Taiwan Recruiting

Study contacts

• Study coordinator: Ting-Yung Chang, M.D.
• Email: tingyungchang@gmail.com
• Phone: 886-2-2875-7808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.