ArticleBiomedicines2024
Trans-Coronary Sinus Intra-Septal Radiofrequency Ablation (TIRA) for Hypertrophic Obstructive Cardiomyopathy: First-in-Human Results.
Article in Biomedicines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04770142 (The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System), which is not on this map. Cited by 2 papers.
What it found
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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.
The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System (TIRA Catheter) to Treat Hypertrophic Obstructive Cardiomyopathy : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study
Who cites it
2 citing papers in PubMed.
- Engineering cardiac regeneration using stem cells: Cellular sources, differentiation signatures, targeted delivery, and functional recovery.Regenerative therapy · 2026Review
- Association of Coronary Sinus Flow with Long-Term Risk of Acute Coronary Syndrome and Composite Cardiovascular Events.Biomedicines · 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
6 authors.
Funding
Abstract
backgroundCurrent treatments for hypertrophic obstructive cardiomyopathy (HOCM), including medication, surgery, and alcohol septal ablation (ASA), have limitations in terms of efficacy and safety. To address these challenges, we developed the trans-coronary intra-septal radiofrequency ablation (TIRA) device.
methodsThis first-in-human trial was conducted to assess the efficacy and safety of the TIRA device. Moreover, evaluations were conducted before the procedure and at 3, 6, and 12 months post-procedure using computed tomography, magnetic resonance imaging, echocardiography, and the 6 min walk distance (6MWD) test.
resultsFour patients were enrolled, and follow-up imaging at 3, 6, and 12 months showed a reduction in the interventricular septal (IVS) thickness (baseline mean: 22.6 mm; 12-month mean: 18.9 mm) and a decrease in the LVOT pressure gradient at 12 months (resting baseline mean: 84.64 mmHg; resting 12-month mean: 43.56 mmHg; Valsalva baseline mean: 129.96 mmHg; Valsalva 12-month mean: 108.16 mmHg). However, reductions in the IVS thickness on echocardiography and improvements in 6MWD were observed in only two patients.
conclusionsNo significant adverse events, such as arrhythmias or vascular injuries, were reported. These findings suggest that the TIRA device may be a safe and effective option for treating HOCM. However, further studies are required to confirm these results.
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