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NCT Number: NCT06960252

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, Outside US, 112, Taiwan

Location status: Recruiting

Location contact

Ting-Yung Chang

CONTACT

[email protected]

0911681873

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who sign the informed consent forms, and allow to be followed.
Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
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.
Patients with age equal or greater than 20 years old regardless of gender.

Exclusion criteria

The presence of an atrial or ventricular thrombus.
Patients who are allergic to or unsuitable for use with the contrast media.
Pregnant patients or patients who are unavailable to receive X-ray.
Patients with severe renal insufficiency. (Glomerular Filtration Rate [GFR] < 15 mg/dl or under dialysis)
Patients had autonomic nervous system disorder (e.g. respiratory apnea).
Patients with age less than 20 years old or greater than 90 years old regardless of gender.
Contraindications to anticoagulation.

Treatment and study plan

OPTRELL™ Mapping Catheter

Device

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.

Primary outcomes

Efficacy endpoint

Time frame: 12 months

The endpoints are recurrence of all atrial arrhythmia, including AF, atrial flutter, and atrial tachycardia, and defined as an episode lasting > 30 seconds, 3 months after the ablation, during follow-up with ambulatory ECG monitoring every 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting-Yung Chang, M.D.

CONTACT

[email protected]

886-2-2875-7808

Sponsors and collaborators

Lead sponsor

Ting-Yung Chang

Other Gov

Registry information

Official study title

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

Acronym: CLM in AF

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 7, 2025
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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