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

February 24, 2025 updated by: Xu Liu, Shanghai Chest Hospital

Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiofrequency ablation unit
The patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed.
Procedure: Radiofrequency ablation
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
Experimental: The pulse field ablation group
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
Procedure: Pulse Field Ablation (PFA)
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieve persistent mitral isthmus block
Time Frame: Immediate post-operative mitral isthmus block rate.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
Time Frame: During the 3-month post-operative follow-up.
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
Time Frame: During the 3-month post-operative follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 24, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIDAF-PFA vs RF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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