Atrial Fibrillation (AF)NCT07353775
Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter
An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Flutter
- What is being tested?
- ICE-guided CTI ablation with PFA
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 15 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.
Who may be able to join
- Paroxysmal or persistent atrial fibrillation
- Aged 18 years or older
- Scheduled for CTI ablation
- Able and willing to provide written informed consent
Who cannot join
- Previous CTI ablation
- Significant congenital heart disease or structural anomaly affecting the CTI
- Active intracardiac thrombus
- Pregnancy or lactation
- Severe renal/hepatic insufficiency
- Active systemic infection or sepsis
- Life expectancy of less than 12 months
- Unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Song Zuo, Doctoral, +86-18801427775, song_zuo@126.com
About this study
Official title: Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety
This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). The main question it aims to answer is:
Is the circular-shaped PFA catheter an effective and safe tool for achieving acute success for CTI ablation? Patients undergoing CTI ablation with a circular-shaped PFA catheter will be prospectively enrolled.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter
- Being tested
- ICE-guided CTI ablation with PFA
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE-guided CTI ablation with PFAProcedure or surgery
Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Success of CTI Block
Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period.
Measured: Within the ablation procedure
Secondary outcomes (5)
CTI Procedural Time
Measured: Within the ablation procedure
Total PF Application Time
Measured: Within the ablation procedure
Number of PFA Applications
Measured: Within the ablation procedure
Procedure-related Complications
Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related.
Measured: Within 30 days after the ablation procedure
Freedom from Any Atrial Arrhythmia
Arrhythmia recurrence is defined as any documented atrial tachyarrhythmia (atrial flutter, atrial fibrillation, or atrial tachycardia) lasting ≥30 seconds, confirmed by ECG or ambulatory monitoring.
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 posted20 Jan 2026
- Study start15 Jan 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (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.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353775
- Sponsor's protocol ID
- PFA-CTI ablation
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety
- ClinicalTrials.gov ID
- NCT07353775
- Acronym / sponsor ID
- PFA-CTI ablation
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). The main question it aims to answer is:
Is the circular-shaped PFA catheter an effective and safe tool for achieving acute success for CTI ablation? Patients undergoing CTI ablation with a circular-shaped PFA catheter will be prospectively enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.
Key inclusion criteria (4 listed)
- Paroxysmal or persistent atrial fibrillation
- Aged 18 years or older
- Scheduled for CTI ablation
- Able and willing to provide written informed consent
Key exclusion criteria (8 listed)
- Previous CTI ablation
- Significant congenital heart disease or structural anomaly affecting the CTI
- Active intracardiac thrombus
- Pregnancy or lactation
- Severe renal/hepatic insufficiency
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 |
|---|---|---|
| ICE-guided CTI ablation with PFACavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography | Procedure or surgery | – |
Primary outcome
Acute Success of CTI Block
Time frame: Within the ablation procedure
Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period.
5 secondary outcomes
CTI Procedural Time
Time frame: Within the ablation procedure
Total PF Application Time
Time frame: Within the ablation procedure
Number of PFA Applications
Time frame: Within the ablation procedure
Procedure-related Complications
Time frame: Within 30 days after the ablation procedure
Freedom from Any Atrial Arrhythmia
Time frame: 12 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 20 Jan 2026.
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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) and Atrial Flutter, run by Beijing Anzhen Hospital at 1 site in China.
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 8 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 20 Jan 2026. 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 China. 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 Song Zuo, Doctoral (+86-18801427775, song_zuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Success of CTI Block (time frame: Within the ablation procedure). 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 20 Jan 2026.