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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: Radiofrequency ablation; Procedure: Pulse Field Ablation (PFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06850064

MIDAF-PFA vs RF

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

1. Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
2. 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

1. Pregnant or breastfeeding women.
2. Presence of left atrial thrombus on preoperative imaging.
3. Life expectancy less than 1 year.
4. Coagulation disorders or contraindications to anticoagulant therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Radiofrequency ablation unit

Active Comparator group

Description:

The patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed.

Treatment:

Procedure: Radiofrequency ablation

The pulse field ablation group

Experimental group

Description:

The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.

Treatment:

Procedure: Pulse Field Ablation (PFA)