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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation unit | Active Comparator | The patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed. |
|
| The pulse field ablation group | Experimental | The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Field Ablation (PFA) | Procedure | The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieve persistent mitral isthmus block | After mitral isthmus block, wait for 20 minutes, and obtain persistent MI block after the waiting period. | Immediate post-operative mitral isthmus block rate. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the 3-month post-operative follow-up. |
| The safety endpoint |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liu | Contact | 18367527058 | 18367527058@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| Radiofrequency ablation | Procedure | In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure. |
|
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. |
| During the 3-month post-operative follow-up. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000092723 | Irreversible Electroporation Therapy |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000092722 | Electroporation Therapies |
| D013812 | Therapeutics |
| D018274 | Electroporation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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