Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2026
Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06271967 (A Study of FOCAL Pulsed Field Ablation With the TactiFLEX SE Catheter and Volt Generator for the Treatment of Paroxysmal Atrial Fibrillation), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study of FOCAL Pulsed Field Ablation With the TactiFLEX SE Catheter and Volt Generator for the Treatment of Paroxysmal Atrial Fibrillation (FOCALFLEX)
Who cites it
1 citing paper in PubMed.
- Successful pulsed field ablation for refractory premature ventricular contractions using a novel dual-energy focal catheter: a case report.European heart journal. Case reports · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
aimsA dual-energy ablation system was developed to optimize targeted energy delivery via a flexible-tip, contact-force sensing catheter with electroanatomic mapping integration. This is the first report of long-term safety and effectiveness results of this system for ablation of paroxysmal atrial fibrillation (PAF). METHODS AND
resultsThe FOCALFLEX study is a prospective, multicentre study. Patients with PAF were enrolled between August 2024 and January 2025, with 144 patients (62.0 ± 10.0 years, 62.6% male) undergoing ablation with the TactiFlex PFA System at 21 sites worldwide. Primary safety and effectiveness endpoints were the rate of pre-defined serious adverse events within 7 days and the 6-month freedom from documented AF/AFL/AT episodes >30 s after a 90-day blanking period.Pulmonary vein isolation (PVI) was performed in each case with pulsed field required for posterior left atrium (LA) ablation and radiofrequency (RF) for cavotricuspid isthmus or near coronary arteries. Non-PV targets and modality were at physician's discretion. Acute effectiveness was confirmed via entrance block and post-ablation LA voltage map after a 20-min waiting period and was achieved in 99.6% (566/568) of treated PVs with 95.5 ± 37.1 pulsed field ablation (PFA) applications/patients. Procedure, fluoroscopy, LA dwell, and PV ablation times were 112.2 ± 29.5, 7.6 ± 5.7, 81.1 ± 19.7, and 47.4 ± 16.4 min, respectively. There were two (1.4%) primary safety events. At 6 months, 81.0% of subjects were free from documented arrhythmia recurrence and the protocol-defined primary effectiveness rate was 79.6%. There was one repeat ablation (0.7%) after the blanking period through 6 months.
conclusionThe FOCALFLEX study results demonstrate safety and effectiveness of a novel dual-mode RF/PFA system through 6 months of follow-up to treat symptomatic, recurrent PAF. CLINICAL
trial registrationClinicalTrials.gov Identifier: NCT06271967.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.