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NCT06014996: InsightPFA
InsightPFA Trial of the LotosPFA Catheter
NA trial testing Pulsed Field Ablation (PFA) Therapy in Arrhythmias, Cardiac in 292 participants. Completed in 3 July 2025.
9 June 2025
Quick facts
| Lead sponsor | Insight Medtech Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 292 |
| Start date | 4 September 2023 |
| Primary completion | 9 June 2025 |
| Estimated completion | 3 July 2025 |
| Sites | 10 locations across China |
Drugs / interventions tested
- Pulsed Field Ablation (PFA) Therapy
- Radiofrequency Ablation(RAF)Therapy
Conditions studied
- Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
- Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Sponsor
Insight Medtech Co., Ltd.
Who can join
Adults 18 to 75, any sex, with Arrhythmias, Cardiac or Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intraprocedural activated clotting time and heparin dosage in pulsed field ablation of paroxysmal atrial fibrillation.
Ma C, Xiao X, Chen Q, Li W, et al · · 2025 · cited 2× · PMID 40066349 · DOI 10.3389/fcvm.2025.1501716 -
Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial.
Lin W, Chu H, Wang C, Chang D, et al · · 2025 · cited 1× · PMID 41338842 · DOI 10.1016/j.jacc.2025.09.1593 -
Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation.
Lin W, Pu S, Chu H, Chang D, et al · · 2025 · cited 1× · PMID 39853845 · DOI 10.1111/jce.16573
Verify or expand the search:
- PubMed search for NCT06014996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pulsed Field Ablation (PFA) Therapy
Trials testing the same drug.
- NCT04524364 — A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible El · NA · completed
Other recruiting trials for Arrhythmias, Cardiac
Currently open trials in the same condition.
- NCT07276139 — PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD · active not recruiting
- NCT06954610 — Cardiac Assessment for Recurrent Stroke Risk Evaluation in Atrial Fibrillation · recruiting
- NCT06360939 — Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease · NA · recruiting
- NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
- NCT06358391 — To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Pu · NA · 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 NCT06014996 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insight Medtech Co., Ltd.
- Last refreshed: 17 August 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/NCT06014996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing