New Study Aims to Demonstrate Positive Impact of Innovative Ablation Technology on Patient Outcomes
St. Petersburg, Fl (June 23, 2021) – Bayfront Health St. Petersburg today announced that it is participating in a new global clinical study designed to establish the safety and efficacy of an investigational ablation system for patients experiencing typical atrial flutter. Bayfront Health St. Petersburg is one of up to 20 centers participating in the U.S. and Europe in the study of the AcQBlate FORCE Sensing Ablation System.
“The incidence of atrial arrhythmias is increasing every year. As physicians, we continuously search for new and innovative medical technologies that can deliver safer and more effective treatment options for our ablation patients,” said Daniel Masvidal, MD, cardiologist at Bayfront Health St. Petersburg. “We are honored to be the only healthcare facility in Pinellas County to participate in this study and to be able to bring it to our patients who qualify.”
In the U.S., typical atrial flutter ablation procedures currently account for approximately 30% of all cardiac ablation procedures and are expected to reach 200,000 annually by 20251, as the number of people with risk factors including obesity, hypertension, diabetes and high blood pressure continues to steadily increase. If not treated, typical atrial flutter carries the potential for serious health problems. These include increased risk of deep vein blood clots, heart failure, stroke and proarrhythmia, where new, often more dangerous arrhythmias can emerge, including atrial fibrillation.2,3 For these patients, arrhythmia management is most easily achieved with ablation.4
Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE Sensing Ablation System, developed by Acutus Medical, Inc. (Carlsbad, Calif.), provides physicians with real-time contact force being applied to the heart during ablations. This information helps guide safe and effective procedures with the potential to improve patient outcomes.5 The AcQBlate FORCE Sensing Ablation System’s catheter uniquely features a gold tip, providing more efficient energy delivery and effective lesion creation in less time.6,7 AcQBlate FORCE can operate in a standalone manner or in conjunction with a compatible 3D cardiac mapping system.
To qualify for the AcQForce Flutter study, participants must be at least 18 years of age, have had at least one documented episode of typical atrial flutter within six months prior to enrollment and be clinically indicated for a first-time catheter ablation of atrial flutter.
Individuals interested in additional information on the AcQForce Flutter study are encouraged to visit ClinicalTrials.gov.
1Erik J. Bracciodieta, Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0059, June 2019.
2Bracciodieta, Erik J. Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0059, June 2019.
3Ghali WA, Wasil BI, Brant R et al. “Atrial flutter and the risk of thromboembolism: a systematic review and meta-analysis.” Am J Med 2005; 118:101-7.
3Afzal M et al., “Use of contact force sensing technology during radiofrequency ablation reduces recurrence of atrial fibrillation: A systematic review and meta-analysis”, Heart Rhythm 2015, vol. 12, 1990-1996
4Natale, Andrea, et al. “Prospective Randomized Comparison of Antiarrhythmic Therapy Versus First-Line Radiofrequency Ablation in Patients with Atrial Flutter.” Journal of the American College of Cardiology, Vol. 35, No. 7, 2000.
5Afzal M, et al. “Use of contact force sensing technology during radiofrequency ablation reduces recurrence of atrial fibrillation: A systematic review and meta-analysis”, Heart Rhythm 2015, vol. 12, 1990-1996
6Linhart M. et al., Superiority of Gold Compared to Platinum Tip Irrigated Catheter Ablation of the Pulmonary Veins and the Cavotricuspid Isthmus: A Randomized Study Comparing Tip Temperatures and Cooling Flow Requirements. J Cardiovasc Electrophysiol. 2012 Jul; 23(7): 717–21.
7B. Schmidt, et al., Gold Tip Ablation Facilitates Acute Pulmonary Vein Isolation. A Prospective Randomized Pilot Study. European Heart Journal Volume 34, Issue suppl 1, 1. August 2013.
About Bayfront Health St. Petersburg
The 480-bed Bayfront Health St. Petersburg was founded in 1910. It was acquired October 1, 2020 by Orlando Health, a not-for-profit healthcare organization with $7.1 billion of assets under management. The hospital’s areas of clinical excellence include heart and vascular, surgical services, rehabilitation services, neurosciences, maternity care and – as home to the only state-accredited Level Two Adult Trauma Center in Pinellas County – emergency services and trauma care.
Bayfront Health St. Petersburg is integral to the 3,200-bed Orlando Health system which serves the southeastern United States through 15 wholly-owned hospitals and emergency departments; rehabilitation services, cancer and heart institutes, imaging and laboratory services, wound care centers, physician offices for adults and pediatrics, skilled nursing facilities, an in-patient behavioral health facility, home healthcare services in partnership with LHC Group, and urgent care centers in partnership with CareSpot Urgent Care. Nearly 4,200
physicians, representing more than 80 medical specialties and subspecialties have privileges across the system, which employs nearly 22,000 team members.
As a statutory teaching healthcare organization, Orlando Health hosts more than 325 residents and fellows including more than 40 who are enrolled at Bayfront Health St. Petersburg’s OB/GYN, Family Medicine, Sports Medicine and Pharmacy programs.
In FY20, Orlando Health served nearly 150,000 inpatients and nearly 3.1 million outpatients. During that same time period, the organization provided approximately $760 million in total value to the communities it serves in the form of charity care, community benefit programs and services, community building activities and more. Additional information can be found at https://www.bayfrontstpete.com or follow us on LinkedIn, Facebook, Instagram and Twitter.
About the AcQBlate FORCE Sensing Ablation System
The AcQBlate FORCE Sensing Ablation System is comprised of Acutus Medical’s AcQBlate FORCE catheter, the first force sensing ablation catheter to feature a gold-tip electrode, along with the Qubic Force module, which seamlessly integrates the smallest and most modern RF generator and irrigation pump. The complete AcQBlate FORCE Sensing Ablation System, which received full CE Mark in late 2020, is commercially available in Europe. AcQBlate FORCE is limited by U.S. federal law to investigational use.
About the AcQForce Flutter Clinical Trial
The Acutus Medical AcQForce Flutter clinical research study is a prospective, multi-center, global study designed to confirm the safety and effectiveness of the AcQBlate FORCE Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
About Acutus Medical
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.
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CAUTION: The AcQBlate FORCE Sensing Ablation System is investigational and is limited by United States law to investigational use only.