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A Prospective Real-world Comparison of Petaspline and Focalpoint Pulsed Field Ablation Systems in Paroxysmal Atrial Fibrillation:insights from the PEFACT I registry

A Prospective Real-world Comparison of Petaspline and Focalpoint Pulsed Field Ablation Systems in Paroxysmal Atrial Fibrillation:insights from the PEFACT I registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116711
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal atrial fibrillation

Interventions

Petal-shaped catheter ablation group:None
Punctate catheter ablation group:None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 80; 2.Those who have an unsatisfactory response to antiarrhythmic drug treatment and meet the above diagnostic criteria for paroxysmal atrial fibrillation; 3.Preoperative assessment by cardiac CT and/or esophageal echocardiography indicated that the anatomical structure of the pulmonary veins was suitable for petal-shaped or punctate catheter pulse ablation; 4.Received catheter ablation treatment for the first time;

Exclusion criteria

Exclusion criteria: 1.There is a history of left atrial interventional ablation or cardiac surgery in the past. 2.Persistent or long-lasting persistent atrial fibrillation (AF attacks last for more than 7 days or require drug/electrical cardioversion to be terminated); 3.There is thrombus in the left atrium/left atrial appendage (confirmed by esophageal echocardiography); 4.Accompanied by severe structural heart disease or heart failure, NYHA grade IV, such as: severe valvular heart disease, left ventricular ejection fraction (LVEF) 50mm, etc. 5.There are permanent cardiac implantable electronic devices (such as pacemakers, ICDs); 6.Combined with uncorrected hyperthyroidism or severe liver or kidney dysfunction; 7.There are contraindications for anticoagulant therapy; 8.Pregnant or lactating women; 9.Visitors with mental illnesses or those who are unable to cooperate to complete the follow-up.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
Time to first recurrence;Reablation rate;Acute isolation effect;Intraoperative complications;Pericardial effusion;Thrombotic events;Death from any cause;

Countries

China

Contacts

Public ContactQingxing Chen

Zhongshan Hospital, Fudan University

chen.qingxing@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026