Atrial Fibrillation (AF)NCT06739512
Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation
A study testing Extensive Electro-Anatomical Guided Ablation, Anatomical Guided Ablation and Electrogram Guided Ablation in people with Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Extensive Electro-Anatomical Guided Ablation, Anatomical Guided Ablation and Electrogram Guided Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 1 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
- Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
Who cannot join
- Major valvular diseases needing surgical intervention.
- Presence of a left atrial thrombus on recent imaging.
- Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
- Current Severe Infection.
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
No. 241, West Huaihai Road
Shanghai, Shanghai Municipality, 200000
Xu Liu, MD, +86 021-22200000, drliux@126.com
About this study
Official title: Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Extensive Electro-Anatomical Guided Ablation, Anatomical Guided Ablation, Electrogram Guided Ablation
- Keywords
- 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.
Extensive Electro-Anatomical Guided AblationProcedure or surgery
Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
Anatomical Guided AblationProcedure or surgery
Ablation using PFA. Guided by anatomical landmarks without potential mapping
Electrogram Guided AblationProcedure or surgery
Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical Guided Ablation Group | Placebo comparator | This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping. Receives: Procedure: Anatomical Guided Ablation |
| Electrogram Guided Ablation Group | Active comparator | This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths. Receives: Procedure: Electrogram Guided Ablation |
| Extensive Electro-Anatomical Guided Ablation Group | Experimental | This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting. Receives: Procedure: Extensive Electro-Anatomical Guided Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Arrhythmia Recurrence at 12 Months
Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.
Measured: 12 months after ablation procedure
Secondary outcomes (3)
Procedural Safety
Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.
Measured: From enrollment to completion of follow-up（at least 12 months）
Symptom Relief and Quality of Life Enhancement.
Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).
Measured: From enrollment to completion of follow-up（at least 12 months）
Atrial Fibrillation Burden Reduction
Reduction in atrial fibrillation burden assessed through follow-up evaluations.
Measured: From enrollment to completion of follow-up（at least 12 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 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 Shanghai Chest 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine and Montefiore Medical Center, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine, Yuhuan Second People's Hospital, Changshu Hospital of Traditional Chinese Medicine, Jinan People's Hospital, Xuzhou Central Hospital, The PLA Navy Anqing Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739512
- Sponsor's protocol ID
- EXT-II
- Status last verified
- Dec 2024
- First submitted
- 24 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06739512
- Acronym / sponsor ID
- EXT-II
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- ablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine and Montefiore Medical Center, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine, Yuhuan Second People's Hospital, Changshu Hospital of Traditional Chinese Medicine, Jinan People's Hospital, Xuzhou Central Hospital, The PLA Navy Anqing Hospital
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 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 multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anatomical Guided Ablation Group | Placebo comparator | Procedure: Anatomical Guided AblationThis group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping. |
| Electrogram Guided Ablation Group | Active comparator | Procedure: Electrogram Guided AblationThis group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths. |
| Extensive Electro-Anatomical Guided Ablation Group | Experimental | Procedure: Extensive Electro-Anatomical Guided AblationThis group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
- Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
Key exclusion criteria (4 listed)
- Major valvular diseases needing surgical intervention.
- Presence of a left atrial thrombus on recent imaging.
- Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
- Current Severe Infection.
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 |
|---|---|---|
| Extensive Electro-Anatomical Guided AblationAblation using PFA. Combination of anatomical and electrogram-guided ablation techniques. | Procedure or surgery | Extensive Electro-Anatomical Guided Ablation Group |
| Anatomical Guided AblationAblation using PFA. Guided by anatomical landmarks without potential mapping | Procedure or surgery | Anatomical Guided Ablation Group |
| Electrogram Guided AblationAblation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter. | Procedure or surgery | Electrogram Guided Ablation Group |
Primary outcome
Freedom from Atrial Arrhythmia Recurrence at 12 Months
Time frame: 12 months after ablation procedure
Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.
3 secondary outcomes
Procedural Safety
Time frame: From enrollment to completion of follow-up（at least 12 months）
Symptom Relief and Quality of Life Enhancement.
Time frame: From enrollment to completion of follow-up（at least 12 months）
Atrial Fibrillation Burden Reduction
Time frame: From enrollment to completion of follow-up（at least 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 18 Dec 2024.
- Individual participant dataSharing planned: Yes
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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?
A study testing Extensive Electro-Anatomical Guided Ablation, Anatomical Guided Ablation and Electrogram Guided Ablation in people with Atrial Fibrillation (AF), run by Shanghai Chest 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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. Some participants in this study may receive a placebo. 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 Xu Liu, MD (+86 021-22200000, drliuxu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Arrhythmia Recurrence at 12 Months (time frame: 12 months after 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 18 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.