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NCT07294742: PFApple-Per AF
Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation
NA trial testing a novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation in 34 participants. Participants enrolled and being followed up; not accepting new ones.
29 May 2025
Quick facts
| Lead sponsor | The Third People's Hospital of Chengdu |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 6 November 2024 |
| Primary completion | 29 May 2025 |
| Estimated completion | 15 June 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- a novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter
Conditions studied
- Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Sponsor
The Third People's Hospital of Chengdu
Who can join
Adults 18 to 75, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial aims to evaluate the safety and effectiveness of pulmonary vein isolation (PVI) and linear ablation using a large-focal pulsed field ablation (PFA) catheter in patients with persistent atrial fibrillation (perAF). The study will address two primary questions: 1. Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation? 2. Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping? Study Design and Intervention Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions. Participant Follow-up Protocol Enrolled participants will complete the following assessments: 1. Index Procedure: PVI and linear ablation with the PFApple PFA catheter. 2. Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability. 3. Clinical Follow-up: Scheduled visits at 7 days, 30 days, 3 months, 6 months, and 12 months post-procedure. Atrial tachyarrhythmia recurrence is assessed via 12-lead electrocardiography at each visit and 24-hour or 7-day Holter monitoring at the 6- and 12-month time points.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07294742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Persistent Atrial Fibrillation
Currently open trials in the same condition.
- NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
- NCT07535268 — REPRESENT-PF Registry · recruiting
- NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · NA · recruiting
Other The Third People's Hospital of Chengdu trials
Trials by the same sponsor.
- NCT07321002 — PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation · NA · not yet recruiting
- NCT07301190 — FIH Study of PFLotus in Persistent Atrial Fibrillation · NA · recruiting
- NCT06811194 — PRIor Myocardial Infarction Identification on Electrocardiogram · enrolling by invitation
- NCT06699368 — Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influenc · NA · not yet recruiting
- NCT06694610 — A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibril · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07294742 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Third People's Hospital of Chengdu
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07294742.
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