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

NCT06850064 | Not Yet Recruiting DMC

• 1 other identifier: MIDAF-PFA vs RF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atrial Fibrillation (AF)

Keywords

Mitral Isthmus; PFA

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.

  During the 3-month post-operative follow-up.

• The safety endpoint

  During the 3-month post-operative follow-up.

Study Arms (2)

Radiofrequency ablation unit

ACTIVE COMPARATOR

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

Procedure: Radiofrequency ablation

The pulse field ablation group

EXPERIMENTAL

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

Procedure: Pulse Field Ablation (PFA)

Interventions

Pulse Field Ablation (PFA) PROCEDURE

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

The pulse field ablation group

Radiofrequency ablation PROCEDURE

In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.

Radiofrequency ablation unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Xu Liu

CONTACT

18367527058; 18367527058@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: February 24, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)