Novel catheter meets primary endpoints in trial of treatment for right atrial flutter
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A trial of a gold-tipped contact force-sensing catheter for treatment of patients with atrial flutter met its primary endpoints, researchers reported at AF Symposium.
For the prospective, nonrandomized AcQForce Flutter study, researchers evaluated the safety and efficacy of the gold-tipped contact force-sensing catheter (AcQBlate, Acutus Medical) in 110 patients with right atrial typical flutter at 24 global sites.
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In the cohort, 100% of patients achieved the primary safety endpoint of freedom from prespecified device- or procedure-related serious adverse events at 7 days, 94% achieved the primary effectiveness endpoint of demonstration of bidirectional block at least 20 minutes after the last radiofrequency application and 98% achieved the observational effectiveness endpoint of freedom from recurrent cavotricuspid isthmus-dependent atrial flutter off of antiarrhythmic drugs at 30 days, Gery Tomassoni, MD, electrophysiologist at Baptist Health in Lexington, Kentucky, said during a presentation.
The researchers also compared certain trial results with those from the BLOCk-CTI investigational cohort treated with an existing catheter (Blazer, Boston Scientific). Fluoroscopy time was 10 minutes in the AcQForce Flutter study compared with 17 minutes in the BLOCk-CTI study (P < .0001), ablation duration was 13 minutes in the AcQForce Flutter study compared with 20 minutes in the BLOCk-CTI study (P = .0001) and irrigation volume was 250 mL in the AcQForce Flutter study compared with 699 mL in the BLOCk-CTI study (P < .0001), according to the researchers.
“AcQBlate’s novel gold-tip ablation catheter performed extremely well during the clinical [investigational device exemption] atrial flutter cases,” Tomassoni said in a press release. “Short procedural times, stable contact force and less irrigation volume contributed to efficient and safe ablation procedures. The delivery of low irrigation volumes during ablation should result in better fluid management and post-procedure patient recovery.”
Editor's Note: This article was amended on Feb. 15, 2023 to reflect updates to the data.
Reference:
- Acutus Medical. www.wcia.com/business/press-releases/globenewswire/8742742/late-breaking-acqforce-flutter-trial-meets-primary-endpoint-for-safety-and-efficacy-with-the-first-gold-tipped-contact-force-sensing-ablation-catheter. Published Feb. 6, 2023. Accessed Feb. 9, 2023.
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Tomassoni G, et al. Late Breaking Clinical Trials and First Report Investigations and Best Abstract Award. Presented at: AF Symposium; Feb. 2-4, 2023; Boston.
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