Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation (PRAISE)

January 23, 2025 updated by: Beijing Anzhen Hospital

Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation: A Randomized, Open-label, Non-inferior Study

This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.

Participants will:

Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.

In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.

Study Type

Interventional

Enrollment (Estimated)

700

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

  • China
      • Beijing, China
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:

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:

  • 18-80 years
  • Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years)
  • Left atrial diameter on parasternal long-axis view of echocardiogram < 50 mm
  • Agree to be randomly assigned to the ablation strategy and able to follow up

Exclusion Criteria:

  • Atrial fibrillation due to reversible causes
  • LVEF < 30%
  • Severe congenital heart disease
  • Severe liver or kidney dysfunction (eGFR < 15, Child-Pugh grade 3), or history of dialysis
  • History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement
  • History of pacemaker implantation, left atrial appendage closure, or patent foramen ovale closure
  • Contraindications to oral anticoagulation
  • Contraindications to right or left heart catheterization
  • Pregnancy
  • Life expectancy < 1 year (e.g., advanced malignancy, end-stage renal disease)
  • Currently enrolled in another trial evaluating medical devices or drugs
  • Other situations where the investigator determines the subject is unsuitable for the study

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
Experimental: Pulsed Field Ablation
Device: Pulsed Field Ablation
Patients will be treated with pulsed field ablation for atrial fibrillation.
Active Comparator: Radiofrequency Ablation
Device: Radiofrequency Ablation
Patients will be treated with radiofrequency ablation for atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial fibrillation lasting for >30s in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial tachycardia and atrial flutter episodes in 12 months after the index ablation procedure
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial arrhythmia in the absence of antiarrhythmic therapy in 12 months after multiple ablation procedure (excluding a blanking period of 3 months)
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
The atrial fibrillation burden (percentage of time) monitored over 12 months
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Cardiovascular-related hospitalizations in 12 months after the index ablation procedure
Time Frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Perioperative complications in 30 days after the index ablation procedure
Time Frame: From the end of the ablation to the 30 days follow-up
Cardiac tamponade or perforation, permanent phrenic nerve palsy, acute coronary artery occlusion, stroke/thromboembolism/transient ischemic attack, pulmonary vein stenosis, left atrial-esophageal fistula, vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula), coronary artery spasm, renal failure due to hemolysis, death, and other treatment-related complications requiring intervention or prolonging hospitalization.
From the end of the ablation to the 30 days follow-up

Collaborators and Investigators

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

Sponsor

Beijing Anzhen 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 15, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-PeAF ablation

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

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.

Clinical Trials on Persistent Atrial Fibrillation

Clinical Trials on Radiofrequency Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe