RecruitingNCT06960252

Cycle-Length Mapping in Patients With Non-paroxysmal Atrial Fibrillation

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


Sponsor

Ting-Yung Chang

Enrollment

80 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The critical atrial substrates in maintaining persistent atrial fibrillation might be identified by Cycle-Length Mapping (CLM) module. Based on the results of multicenter study in Cycle-Length Mapping between Taipei Veterans General Hospital (Professor Shih-Ann Chen) and IRCCS San Donato Policlinic (Professor Carlo Pappone), targeted CLM driver-ablation provided significant benefits in terms of arrhythmia freedom in the treatment of persistent AF. These findings support a patient-tailored, mapping-based strategy for individuals affected by non-paroxysmal AF. The new ultra-high density mapping catheter, OPTRELL, will be available soon in Taiwan. Therefore, we proposed that the degree of atrial interstitial fibrosis detected by using both unipolar and bipolar voltage map in sinus rhythm and CLM in AF with OPTRELL™ Mapping Catheter would be further better characterization of the atrial substrate and could be potentially critical targeted in eliminating the sources of AF. As additional substrate mapping provided benefits compared to PVI alone in patients with persistent AF, we hypothesize that combination of electrophysiological and substrate-guided ablation strategy using CLM module with OPTRELL™ Mapping Catheter could be used to guide radiofrequency ablation in the patient with non-paroxysmal atrial fibrillation.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a special heart mapping technique for people with a type of irregular heartbeat called persistent or long-standing atrial fibrillation (AFib). The technique maps the electrical cycle lengths inside the heart to guide treatment. Researchers want to see if this approach leads to better outcomes. **You may be eligible if...** - You are 20 years or older - You have AFib that lasts more than 7 days, or AFib that needed medication or electrical shock to restore normal rhythm - You have already tried at least one heart rhythm medication, but it didn't work or you couldn't tolerate it **You may NOT be eligible if...** - You have a blood clot in your heart - You are allergic to contrast dye used in imaging - You are pregnant or cannot undergo X-ray - You have very poor kidney function (GFR below 15) or are on dialysis - You have an autonomic nervous system disorder (like sleep apnea) - You are under 20 or over 90 years old - You cannot take blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOPTRELL™ Mapping Catheter

PVI plus substrate modification of LA chamber coexisting with low unipolar voltage (\< 3.0 mv) or bipolar voltage (\< 0.5 mv) in SR and stable (STD \< 30), fast AF CL detected by CLM module and OPTRELL™ Mapping Catheter.


Locations(1)

Taipei Veterans General Hospital

Taipei, Outside US, Taiwan

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NCT06960252


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