Last reviewed · How we verify
NCT06271967
FOCALFLEX (CE Mark) Study
NA trial testing TactiFlex™ Ablation Catheter Sensor Enabled™ in Atrial Fibrillation Paroxysmal in 150 participants. Completed in 19 January 2026.
9 July 2025
Quick facts
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 15 August 2024 |
| Primary completion | 9 July 2025 |
| Estimated completion | 19 January 2026 |
| Sites | 24 locations across Denmark, France, Italy, Netherlands, Belgium, Austria, United Kingdom, Germany |
Drugs / interventions tested
- TactiFlex™ Ablation Catheter Sensor Enabled™
Conditions studied
- Atrial Fibrillation Paroxysmal — all drugs for Atrial Fibrillation Paroxysmal →
Sponsor
Abbott Medical Devices — full company profile →
Who can join
18 and older, any sex, with Atrial Fibrillation Paroxysmal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed Field Ablation Software for the treatment of symptomatic, recurrent paroxysmal atrial fibrillation (PAF).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study.
Manninger M, Scherr D, Bulava A, Kalman J, et al · · 2026 · PMID 42097576 · DOI 10.1093/europace/euag108 -
Latest Advances and Ongoing Challenges in Pulsed Field Ablation.
Vázquez-Calvo S, Poletaev V, Verma A. · · 2026 · PMID 41835109 · DOI 10.15420/aer.2025.32
Verify or expand the search:
- PubMed search for NCT06271967
- 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.
- NCT06557876 — The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation · NA · recruiting
- 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 Abbott Medical Devices trials
Trials by the same sponsor.
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- NCT07509658 — TriClip Japan Post-Approval Study · recruiting
- NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
- NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · 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 NCT06271967 (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 Abbott Medical Devices
- Last refreshed: 5 February 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/NCT06271967.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing