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

NCT06960252 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-09-09

No results posted yet for this study

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)

Interventions

DEVICE

OPTRELL™ 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.

Sponsors & Collaborators

  • Ting-Yung Chang

    lead OTHER_GOV

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960252 on ClinicalTrials.gov