NCT06791629

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2025Feb 2027

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 19, 2025

Last Update Submit

January 23, 2025

Conditions

Persistent Atrial FibrillationRadiofrequency Catheter AblationPulsed Field Ablation

Keywords

persistent atrial fibrillationRadiofrequency Catheter Ablationpulsed field ablation

Outcome Measures

Primary Outcomes (1)

  • 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)

    From the end of the 3-month blanking period post-ablation to the 12-month follow-up

Secondary Outcomes (7)

  • Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure

    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)

    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

    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)

    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

    From the end of the 3-month blanking period post-ablation to the 12-month follow-up

  • +2 more secondary outcomes

Study Arms (2)

Radiofrequency Ablation

ACTIVE COMPARATOR
Device: Radiofrequency Ablation

Pulsed Field Ablation

EXPERIMENTAL
Device: Pulsed Field Ablation

Interventions

Pulsed Field AblationDEVICE

Patients will be treated with pulsed field ablation for atrial fibrillation.

Pulsed Field Ablation
Radiofrequency AblationDEVICE

Patients will be treated with radiofrequency ablation for atrial fibrillation.

Radiofrequency Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Deyong Long

CONTACT

+86 135 2295 8166dragon2008@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

February 15, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

February 15, 2027

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)