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Recruiting NCT06960252

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

— Observational Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OPTRELL™ Mapping Catheter.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Efficacy endpoint [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Taipei Veterans General Hospital — Taipei

Identifiers

NCT: NCT06960252 · 2025-01-013AC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗