Atrial Fibrillation (AF)CLM in AFNCT06960252
Cycle-Length Mapping in Patients With Non-paroxysmal Atrial Fibrillation
An observational study of Atrial Fibrillation (AF), run by Ting-Yung Chang at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- OPTRELL™ Mapping Catheter
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-paroxysmal AF
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Outside US, 112
Ting-Yung Chang, 0911681873, tingyungchang@gmail.com
About this study
Official title: A Prospective Study on the Cycle-Length Mapping Using the OPTRELL™ Mapping Catheter in Patients With Non-paroxysmal Atrial Fibrillation
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)
- Being tested
- OPTRELL™ Mapping Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTRELL™ Mapping CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| non-paroxysmal AF | non-paroxysmal AF admitted for catheter ablation Receives: Device: OPTRELL™ Mapping Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Aug 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting-Yung Chang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ting-Yung Chang, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960252
- Sponsor's protocol ID
- 2025-01-013AC
- Acronym
- CLM in AF
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Cycle-Length Mapping Using the OPTRELL™ Mapping Catheter in Patients With Non-paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06960252
- Acronym / sponsor ID
- CLM in AF / 2025-01-013AC
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ting-Yung ChangOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-paroxysmal AF | – | Device: OPTRELL™ Mapping Catheternon-paroxysmal AF admitted for catheter ablation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-paroxysmal AF
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTRELL™ Mapping CatheterPVI 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. | Device | non-paroxysmal AF |
Primary outcome
Efficacy endpoint
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Ting-Yung Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yung Chang, M.D. (886-2-2875-7808, tingyungchang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.