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

NCT06960252 | Recruiting FDA Device

• 1 other identifier: 2025-01-013AC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Efficacy endpoint

  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.

  12 months

Study Arms (1)

non-paroxysmal AF

non-paroxysmal AF admitted for catheter ablation

Device: OPTRELL™ Mapping Catheter

Interventions

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.

non-paroxysmal AF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non-paroxysmal AF

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ting-Yung Chang: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Outside US, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ting-Yung Chang, M.D.

CONTACT

886-2-2875-7808; tingyungchang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

TW (1)