Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed Field Ablation
DevicePatients will be treated with pulsed field ablation for atrial fibrillation.
Radiofrequency Ablation
DevicePatients will be treated with radiofrequency ablation for atrial fibrillation.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Radiofrequency AblationActive comparator 1 intervention
Group B: Pulsed Field AblationExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
From the end of the 3-month blanking period post-ablation to the 12-month follow-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: