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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Ting-Yung Chang, M.D.
tingyungchang@gmail.com
886-2-2875-7808
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Treatments
non-paroxysmal AF
non-paroxysmal AF admitted for catheter ablation
Related Therapeutic Areas
Sponsors
Leads: Ting-Yung Chang

This content was sourced from clinicaltrials.gov