Atrial Fibrillation (AF)NCT06850064
Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
A study testing Pulse Field Ablation (PFA) and Radiofrequency ablation in people with Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study 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?
- Pulse Field Ablation (PFA) and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to 1 Dec 2025
- 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
- 1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:
- Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
- Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).
- 3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.
Who cannot join
- Pregnant or breastfeeding women.
- Presence of left atrial thrombus on preoperative imaging.
- Life expectancy less than 1 year.
- Coagulation disorders or contraindications to anticoagulant therapy.
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
Shanghai Chest Hospital
Shanghai
Xu Liu, 18367527058, 18367527058@163.com
About this study
Official title: Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
Read the detailed description
This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter.
Study Design:
Randomized Groups: Patients will be randomly assigned to two groups:
Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulse Field Ablation (PFA), Radiofrequency ablation
- Keywords
- Mitral Isthmus, PFA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Field Ablation (PFA)Procedure or surgery
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
Radiofrequency ablationProcedure or surgery
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation unit | Active comparator | The patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed. Receives: Procedure: Radiofrequency ablation |
| The pulse field ablation group | Experimental | The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. Receives: Procedure: Pulse Field Ablation (PFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve persistent mitral isthmus block
After mitral isthmus block, wait for 20 minutes, and obtain persistent MI block after the waiting period.
Measured: Immediate post-operative mitral isthmus block rate.
Secondary outcomes (2)
Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
During the 3-month post-operative follow-up, episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
Measured: During the 3-month post-operative follow-up.
The safety endpoint
The safety endpoint is a composite of major safety events, including pericardial tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack, persistent (lasting longer than hospitalization) phrenic nerve paralysis, atrioventricular block, pericarditis, vascular access complications requiring intervention, myocardial infarction, angina, myocardial infarction, coronary artery spasm, atrial-esophageal fistula, and death.
Measured: During the 3-month post-operative follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start24 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850064
- Sponsor's protocol ID
- MIDAF-PFA vs RF
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06850064
- Acronym / sponsor ID
- MIDAF-PFA vs RF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Mitral Isthmus, PFA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Feb 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.
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
Detailed description
This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter.
Study Design:
Randomized Groups: Patients will be randomly assigned to two groups:
Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation unit | Active comparator | Procedure: Radiofrequency ablationThe patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed. |
| The pulse field ablation group | Experimental | Procedure: Pulse Field Ablation (PFA)The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:
- Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
- Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).
- 3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women.
- Presence of left atrial thrombus on preoperative imaging.
- Life expectancy less than 1 year.
- Coagulation disorders or contraindications to anticoagulant therapy.
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 |
|---|---|---|
| Pulse Field Ablation (PFA)The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. | Procedure or surgery | The pulse field ablation group |
| Radiofrequency ablationIn the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure. | Procedure or surgery | Radiofrequency ablation unit |
Primary outcome
Achieve persistent mitral isthmus block
Time frame: Immediate post-operative mitral isthmus block rate.
After mitral isthmus block, wait for 20 minutes, and obtain persistent MI block after the waiting period.
2 secondary outcomes
Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
Time frame: During the 3-month post-operative follow-up.
The safety endpoint
Time frame: During the 3-month post-operative follow-up.
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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 Pulse Field Ablation (PFA) and Radiofrequency 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 4 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 27 Feb 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 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 (18367527058, 18367527058@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve persistent mitral isthmus block (time frame: Immediate post-operative mitral isthmus block rate.). 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 27 Feb 2025.