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

Last updated: February 24, 2025
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Flutter

Treatment

Pulse Field Ablation (PFA)

Radiofrequency ablation

Clinical Study ID

NCT06850064
MIDAF-PFA vs RF
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 radiofrequencycatheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional blockat 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

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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Pulse Field Ablation (PFA)
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
December 01, 2025

Study 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

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai,
    China

    Site Not Available

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