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NCT06364215: (SMILE-AF)
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
NA trial testing Farapulse PFA, Pulmonary Vein Isolation alone in Atrial Fibrillation Paroxysmal in 198 participants. Terminated before completion.
16 November 2025
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 8 October 2024 |
| Primary completion | 16 November 2025 |
| Estimated completion | 16 November 2025 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- Farapulse PFA, Pulmonary Vein Isolation alone
- Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Conditions studied
- Atrial Fibrillation Paroxysmal — all drugs for Atrial Fibrillation Paroxysmal →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 21 to 90, any sex, with Atrial Fibrillation Paroxysmal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06364215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation Paroxysmal
Currently open trials in the same condition.
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- NCT06696170 — CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation · NA · recruiting
- NCT06172699 — Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study · active not recruiting
- NCT05549752 — Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Pati · Phase 3 · recruiting
- NCT05292209 — RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring · Phase 2 · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
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 NCT06364215 (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 Brigham and Women's Hospital
- Last refreshed: 19 November 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/NCT06364215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing