Atrial Fibrillation (AF)NCT06745167
Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation
A study testing Pulsed field ablation and Radiofrequency ablation alone 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 compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). 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?
- Pulsed field ablation and Radiofrequency ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 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
- 1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.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, drliuxu@126.com
About this study
Official title: Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial
This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulsed field ablation, Radiofrequency ablation alone
- Keywords
- atrial fibrillation, pulsed field ablation, radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed field ablationProcedure or surgery
Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation.
Radiofrequency ablation aloneProcedure or surgery
Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation
| Study group | Role | What they receive |
|---|---|---|
| Pulsed field ablation | Experimental | Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. Receives: Procedure: Pulsed field ablation |
| Radiofrequency Ablation | Active comparator | Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. Receives: Procedure: Radiofrequency ablation alone |
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 (4)
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 (EHRA scores)
Improvement in clinical symptoms (EHRA scores)
Measured: From enrollment to completion of follow-up（at least 12 months）
Quality of Life (Short Form 36 Health Survey).
quality of life measurements (Short Form 36 Health Survey).
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 posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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, The PLA Navy Anqing Hospital, Jinan People's Hospital, Xuzhou Central Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
- Investigators
- Xu Liu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745167
- Sponsor's protocol ID
- EXT-III
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 20 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06745167
- Acronym / sponsor ID
- EXT-III
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, pulsed field ablation, radiofrequency ablation
- 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, The PLA Navy Anqing Hospital, Jinan People's Hospital, Xuzhou Central Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 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 compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed field ablation | Experimental | Procedure: Pulsed field ablationUtilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. |
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency ablation aloneUsing conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.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 |
|---|---|---|
| Pulsed field ablationUtilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation. | Procedure or surgery | Pulsed field ablation |
| Radiofrequency ablation aloneUsing conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation | Procedure or surgery | Radiofrequency Ablation |
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.
4 secondary outcomes
Procedural Safety
Time frame: From enrollment to completion of follow-up（at least 12 months）
Symptom Relief (EHRA scores)
Time frame: From enrollment to completion of follow-up（at least 12 months）
Quality of Life (Short Form 36 Health Survey).
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 20 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.
Xu Liu principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed field ablation and Radiofrequency ablation alone 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 1 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 20 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. 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 20 Dec 2024.