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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulse Field Ablation (PFA), Radiofrequency ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Procedure Pulse Field Ablation (PFA)
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure. - Procedure Radiofrequency ablation
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
Primary outcome measures
- Achieve persistent mitral isthmus block [Time frame: Immediate post-operative mitral isthmus block rate.]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
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:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06850064 · MIDAF-PFA vs RF