Atrial Fibrillation (AF)NON-FLUORO-LABNCT06719921
Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
A study testing AF ablation, AF ablation in a non-fluoroscopic EP lab and AF ablation in a fluoroscopic lab in people with Atrial Fibrillation (AF), run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- AF ablation, AF ablation in a non-fluoroscopic EP lab and AF ablation in a fluoroscopic lab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 31 May 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age: ≥18 years
- Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
- Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
- The patient is able and willing to provide written informed consent.
Who cannot join
- Patients with contraindication to anticoagulation
- Patients with contraindication to right or left sided cardiac catheterization
- X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
- Serious known concomitant disease with a life expectancy of < 1 year
- MI, CABG, or PCI within the preceding 3 months
- Left atrial diameter >55 mm
Show all 14Show fewer
- LVEF<30%
- NYHA class III or IV
- Awaiting cardiac transplantation or other cardiac surgery within 12 months.
- History of a documented thromboembolic event within the past 6 weeks.
- Heart or vascular malformation that impedes catheter access or vascular puncture.
- Current enrollment in an investigational study evaluating another device or drug.
- Acute illness, active systemic infection, or sepsis.
- Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
Read the detailed description
This study evaluates the clinical efficacy and safety of AF catheter ablation procedures in non-fluoroscopic EP labs, compared to fluoroscopy labs. Non-fluoroscopic labs rely on advanced technologies such as three-dimensional electroanatomic mapping system, intracardiac echocardiography (ICE), contact force sensing catheter and/or pulsed field ablation(PFA), etc...
Participants are randomized into two groups:
- Non-Fluoroscopic Lab Group: Ablation procedures will utilize 3D mapping systems. ICE is mandatory for real-time anatomical visualization, and fluoroscopy is employed only in unforeseen procedural challenges to ensure patient safety.
- Fluoroscopy-equipped Lab Group: Procedures are conducted in a fluoroscopic lab using the same tools and mapping system as non-fluoroscopic lab group, with radiation exposure monitored and minimized according to ALARA principles.
The primary efficacy endpoint assesses treatment success at 12 months, defined as freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) recurrence for more than 30 seconds, as detected by ECG or 7-day Holter. Safety endpoints include a composite of major adverse events such as stroke, tamponade, myocardial infarction, or phrenic nerve injury within 3 months post-procedure. Secondary endpoints focus on procedural metrics, recurrence during the blanking period, adverse event profiles, and changes in quality-of-life forms using the AF Effect on Quality of Life (AFQT) and the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) instruments.
Data collection involves electronic data capture (EDC) systems, with detailed peri-procedural and follow-up evaluations at 3, 6, 9, and 12 months. Each participant undergoes quality-of-life assessments, physical exams, and arrhythmia recurrence monitoring via ECG and 7-day Holter recordings.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- AF ablation, AF ablation in a non-fluoroscopic EP lab, AF ablation in a fluoroscopic lab
- Keywords
- non-fluoroscopic lab, catheter ablation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablationProcedure or surgery
The primary ablation strategy for both groups will be pulmonary vein isolation (PVI).
Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following:
- Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or
- Arrhythmias originating from the specific region requiring intervention.
AF ablation in a non-fluoroscopic EP labOther
This procedure will take place in a non-fluoroscopic lab ( a lab without a fluoroscopy system).
AF ablation in a fluoroscopic labOther
This procedure will take place in a fluoroscopy-equipped lab.
| Study group | Role | What they receive |
|---|---|---|
| Non-Fluoroscopic Lab Group | Experimental | Ablation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization. Receives: Procedure: AF ablation; Other: AF ablation in a non-fluoroscopic EP lab |
| Fluoroscopy-equipped Lab Group | Active comparator | Ablation procedures will be conducted in a fluoroscopic lab. The use of ICE, 3D EP mapping systems, and other tools will follow the same recommendations as in the non-fluoroscopic lab group. Radiation exposure will be closely monitored and minimized in accordance with the ALARA (As Low As Reasonably Achievable) principles when necessary. Receives: Procedure: AF ablation; Other: AF ablation in a fluoroscopic lab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation
The primary endpoint of the study is treatment success from the end of the 90-day blanking period through 12 months after the index procedure. Treatment failure is defined as documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds; continuation or reinitiation of a class I or III AAD after the blanking period; or electrical cardioversion after the blanking period; or repeat catheter ablation for any atrial arrhythmia at any time of follow-up, including during the blanking period. Ablation performed solely for typical right atrial flutter or other supraventricular tachycardia will not constitute treatment failure.
Measured: From enrollment to the end of treatment at 12 months
Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation
The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events:
- Major vascular complication or major bleeding within the first 7 days post procedure.
- Development of a clinically significant pericardial effusion.
- Transient ischemic attack.
- Stroke.
- Myocardial infarction.
- Sinus node dysfunction or high-grade atrioventricular block within 30 days.
- Severe pulmonary vein stenosis.
- Atrial-esophageal fistula, or phrenic nerve injury within 3 months.
- Death.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (8)
Acute Success of the Procedure
The acute success of the procedure is defined as the percentage of procedures achieving the intended acute procedural endpoints, including: 1) Complete PVI, as confirmed by mapping or pacing maneuvers. 2) Immediate restoration and maintenance of sinus rhythm at the end of the procedure, either spontaneously or through cardioversion.
Measured: From the start to the completion of the procedure.
Proportion of Intra-Procedural Conversion to Using X-ray
The percentage of procedures in each group (non-fluoroscopic and conventional DSA lab) that required conversion to X-ray guidance during the ablation procedure. Conversion is defined as the use of fluoroscopy to complete any part of the procedure that could not be accomplished using the assigned guidance modality.
Measured: From the start to the completion of the procedure.
Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation
he percentage of patients experiencing recurrence of AF or AFL/AT during the blanking period (90 days post-ablation).
Measured: from the time of ablation to 90 days post-ablation.
Incidence of Peri-Procedural Complications
The percentage of patients experiencing complications such as cardiac tamponade, stroke, or vascular complications during the peri-procedural period.
Measured: From the start of the procedure to 7 days post-ablation.
Total Procedure Duration
The total time elapsed from the moment of skin puncture to the removal of all catheters and completion of the procedure (skin-to-skin time).
Measured: During the procedure.
Ablation Time
The total time during the procedure when energy was delivered for ablation.
Measured: During the procedure.
Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument
The change in patients' self-reported quality of life related to atrial fibrillation, as measured by the AF Effect on Quality of Life (AFQT) questionnaire. And the change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire.
Measured: From enrollment to the end of treatment at 12 months
Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument
The change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start22 Apr 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 May 2028 (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 Sir Run Run Shaw 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenyang Jiang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719921
- Sponsor's protocol ID
- SRRSH-2025-Research-0052
- Acronym
- NON-FLUORO-LAB
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD collected during this study will not be made publicly available. The decision not to share IPD is based on lack of resources to support secure and compliant data sharing. The study's findings are fully presented in the manuscript, and any additional summary data can be provided upon reasonable request to the corresponding author, subject to ethical considerations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06719921
- Acronym / sponsor ID
- NON-FLUORO-LAB / SRRSH-2025-Research-0052
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- non-fluoroscopic lab, catheter ablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 724 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 6 Dec 2024 (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 randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
Detailed description
This study evaluates the clinical efficacy and safety of AF catheter ablation procedures in non-fluoroscopic EP labs, compared to fluoroscopy labs. Non-fluoroscopic labs rely on advanced technologies such as three-dimensional electroanatomic mapping system, intracardiac echocardiography (ICE), contact force sensing catheter and/or pulsed field ablation(PFA), etc...
Participants are randomized into two groups:
- Non-Fluoroscopic Lab Group: Ablation procedures will utilize 3D mapping systems. ICE is mandatory for real-time anatomical visualization, and fluoroscopy is employed only in unforeseen procedural challenges to ensure patient safety.
- Fluoroscopy-equipped Lab Group: Procedures are conducted in a fluoroscopic lab using the same tools and mapping system as non-fluoroscopic lab group, with radiation exposure monitored and minimized according to ALARA principles.
The primary efficacy endpoint assesses treatment success at 12 months, defined as freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) recurrence for more than 30 seconds, as detected by ECG or 7-day Holter. Safety endpoints include a composite of major adverse events such as stroke, tamponade, myocardial infarction, or phrenic nerve injury within 3 months post-procedure. Secondary endpoints focus on procedural metrics, recurrence during the blanking period, adverse event profiles, and changes in quality-of-life forms using the AF Effect on Quality of Life (AFQT) and the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) instruments.
Data collection involves electronic data capture (EDC) systems, with detailed peri-procedural and follow-up evaluations at 3, 6, 9, and 12 months. Each participant undergoes quality-of-life assessments, physical exams, and arrhythmia recurrence monitoring via ECG and 7-day Holter recordings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Fluoroscopic Lab Group | Experimental | Procedure: AF ablation, Other: AF ablation in a non-fluoroscopic EP labAblation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization. |
| Fluoroscopy-equipped Lab Group | Active comparator | Procedure: AF ablation, Other: AF ablation in a fluoroscopic labAblation procedures will be conducted in a fluoroscopic lab. The use of ICE, 3D EP mapping systems, and other tools will follow the same recommendations as in the non-fluoroscopic lab group. Radiation exposure will be closely monitored and minimized in accordance with the ALARA (As Low As Reasonably Achievable) principles when necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥18 years
- Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
- Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
- The patient is able and willing to provide written informed consent.
Key exclusion criteria (14 listed)
- Patients with contraindication to anticoagulation
- Patients with contraindication to right or left sided cardiac catheterization
- X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
- Serious known concomitant disease with a life expectancy of < 1 year
- MI, CABG, or PCI within the preceding 3 months
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 |
|---|---|---|
| AF ablationThe primary ablation strategy for both groups will be pulmonary vein isolation (PVI). Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following: * Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or * Arrhythmias originating from the specific region requiring intervention. | Procedure or surgery | Fluoroscopy-equipped Lab Group, Non-Fluoroscopic Lab Group |
| AF ablation in a non-fluoroscopic EP labThis procedure will take place in a non-fluoroscopic lab ( a lab without a fluoroscopy system). | Other | Non-Fluoroscopic Lab Group |
| AF ablation in a fluoroscopic labThis procedure will take place in a fluoroscopy-equipped lab. | Other | Fluoroscopy-equipped Lab Group |
Primary outcome
Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation
Time frame: From enrollment to the end of treatment at 12 months
The primary endpoint of the study is treatment success from the end of the 90-day blanking period through 12 months after the index procedure. Treatment failure is defined as documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds; continuation or reinitiation of a class I or III AAD after the blanking period; or electrical cardioversion after the blanking period; or repeat catheter ablation for any atrial arrhythmia at any time of follow-up, including during the blanking period. Ablation performed solely for typical right atrial flutter or other supraventricular tachycardia will not constitute treatment failure.
Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation
Time frame: From enrollment to the end of treatment at 3 months
The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events: * Major vascular complication or major bleeding within the first 7 days post procedure. * Development of a clinically significant pericardial effusion. * Transient ischemic attack. * Stroke. * Myocardial infarction. * Sinus node dysfunction or high-grade atrioventricular block within 30 days. * Severe pulmonary vein stenosis. * Atrial-esophageal fistula, or phrenic nerve injury within 3 months. * Death.
8 secondary outcomes
Acute Success of the Procedure
Time frame: From the start to the completion of the procedure.
Proportion of Intra-Procedural Conversion to Using X-ray
Time frame: From the start to the completion of the procedure.
Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation
Time frame: from the time of ablation to 90 days post-ablation.
Incidence of Peri-Procedural Complications
Time frame: From the start of the procedure to 7 days post-ablation.
Total Procedure Duration
Time frame: During the procedure.
Ablation Time
Time frame: During the procedure.
Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument
Time frame: From enrollment to the end of treatment at 12 months
Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument
Time frame: From enrollment to the end of treatment at 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 Aug 2026.
- Individual participant dataSharing planned: No. The IPD collected during this study will not be made publicly available. The decision not to share IPD is based on lack of resources to support secure and compliant data sharing. The study's findings are fully presented in the manuscript, and any additional summary data can be provided upon reasonable request to the corresponding author, subject to ethical considerations and institutional policies.
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation, AF ablation in a non-fluoroscopic EP lab and AF ablation in a fluoroscopic lab in people with Atrial Fibrillation (AF), run by Sir Run Run Shaw 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 14 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: enrolling by invitation, as of the sponsor's last update on 20 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. 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 Aug 2026.