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NCT06144632: SMARTPULSE PAF
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
NA trial testing THERMOCOOL STSF Bi- Directional Navigation Catheter in Drug Refractory Paroxysmal Atrial Fibrillation in 237 participants. Completed in 30 October 2025.
30 October 2025
Quick facts
| Lead sponsor | Biosense Webster, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 237 |
| Start date | 7 December 2023 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 29 locations across United States |
Drugs / interventions tested
- THERMOCOOL STSF Bi- Directional Navigation Catheter
- TRUPULSE Generator
Conditions studied
- Drug Refractory Paroxysmal Atrial Fibrillation — all drugs for Drug Refractory Paroxysmal Atrial Fibrillation →
Sponsor
Biosense Webster, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Drug Refractory Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06144632
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Drug Refractory Paroxysmal Atrial Fibrillation
Currently open trials in the same condition.
- NCT06676072 — A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF: · NA · active not recruiting
Other Biosense Webster, Inc. trials
Trials by the same sponsor.
- NCT07527299 — A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior · NA · not yet recruiting
- NCT07523750 — A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants Wit · NA · not yet recruiting
- NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
- NCT07428564 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF · NA · not yet recruiting
- NCT07227532 — A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Cathe · 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 NCT06144632 (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 Biosense Webster, Inc.
- Last refreshed: 16 January 2026
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/NCT06144632.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing