NCT06960252Recruiting
Cycle-Length Mapping in Patients With Non-paroxysmal Atrial Fibrillation
A Prospective Study on the Cycle-Length Mapping Using the OPTRELL™ Mapping Catheter in Patients With Non-paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Ting-Yung Chang
- Diseases
- Atrial fibrillation
- NCT number
- NCT06960252
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Aug 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who are allergic to or unsuitable for use with the contrast media.
- Patients had autonomic nervous system disorder (e.g. respiratory apnea).
Lab values
- Patients with severe renal insufficiency. (Glomerular Filtration Rate \[GFR\] \< 15 mg/dl or under dialysis)
Age
- Patients with age less than 20 years old or greater than 90 years old regardless of gender.
Other
- The presence of an atrial or ventricular thrombus.
- Pregnant patients or patients who are unavailable to receive X-ray.
- Contraindications to anticoagulation.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.