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NCT04750798: SECURE
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
trial testing BWI Medical Device in Arrhythmias, Cardiac in 8,000 participants. Currently enrolling.
31 December 2036
Quick facts
| Lead sponsor | Biosense Webster, Inc. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 8,000 |
| Start date | 22 February 2021 |
| Primary completion | 31 December 2036 |
| Estimated completion | 31 December 2037 |
| Sites | 39 locations across France, Denmark, Italy, Netherlands, Belgium, Austria, Sweden, Ireland |
Drugs / interventions tested
- BWI Medical Device
- Varipulse Catheter
- Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
Conditions studied
- Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
Sponsor
Biosense Webster, Inc. — full company profile →
Who can join
Eligibility, any sex, with Arrhythmias, Cardiac. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Workflow and sedation choice with the PFA variable-loop circular catheter in real-world AF procedures: insights from the prospective multi-centre VARIPURE clinical study.
Sommer P, Kronborg MB, Sebag F, Sohns C, et al · · 2026 · PMID 41655229 · DOI 10.1093/europace/euag025
Verify or expand the search:
- PubMed search for NCT04750798
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Arrhythmias, Cardiac
Currently open trials in the same condition.
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- 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
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 NCT04750798 (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 Biosense Webster, Inc.
- Last refreshed: 13 April 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/NCT04750798.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing