Cardiva Medical Announces First Patients Enrolled in The AMBULATE Same Day Discharge Study Using VASCADE® MVP
First Prospective Multi-Center Study Evaluating Same Day Discharge for Patients Undergoing Cardiac Ablation Procedures for Atrial Fibrillation
SANTA CLARA, Calif. — July 16, 2020 — Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced the first patient enrollments in its AMBULATE Same Day Discharge study, the first prospective multi-center study designed to evaluate same-day discharge for patients undergoing cardiac ablation procedures for atrial fibrillation. The study is utilizing the VASCADE MVP Venous Vascular Closure System, which received U.S. Food and Drug Administration (FDA) approval in late 2018. VASCADE MVP is the only marketed vascular closure system proven and labeled specifically for procedures requiring multiple access site venous closure with 6-12 French inner diameter sheaths. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure. In previous studies, VASCADE MVP has been proven to enable earlier ambulation, earlier discharge eligibility and higher patient satisfaction.
The study is a prospective, multi-center, single arm registry that will enroll approximately 150 patients in up to 10 leading U.S. centers to evaluate the clinical benefit of VASCADE MVP to facilitate same day discharge for patients undergoing cardiac ablation procedures for atrial fibrillation. The primary endpoint of the study will report out on the percentage of patients who were successfully discharged on the same day as procedure completion and not require rehospitalization for access site or ablation procedure related complications. A sub-analysis of patients who had previously undergone a cardiac ablation procedure will also be conducted.
“We have found that VASCADE MVP consistently improves patient satisfaction as well as clinical workflow by reducing patient EP Lab time by 15-20 minutes and bedrest time by up to 4 hours,” said Zayd A. Eldadah, MD, PhD, Principal Investigator and Director of Cardiac Electrophysiology at the MedStar Health System in Washington DC and Baltimore. “We are now increasingly comfortable and confident sending patients home in hours, not a day or more, following EP procedures, enabling same-day discharge to become our current standard of care when using VASCADE MVP. We believe this study will validate our real-world experience and that these results will have heightened relevance amid the COVID-19 pandemic, when minimizing hospitalization time is particularly essential.”
“Since launching VASCADE MVP 18 months ago, we have expanded our presence rapidly within many of the largest electrophysiology centers in the U.S.,” said John Russell, President and CEO of Cardiva Medical. “As these sites have implemented a new early ambulation workflow with VASCADE MVP, a growing number of them have taken the next natural step towards the same day discharge of patients after AF ablation as well. Considering recent events and the increasing need and desire to send patients home sooner, we designed this trial to demonstrate the safety of same day discharge for AF ablation patients with VASCADE MVP.”
About Cardiva Medical, Inc.
Cardiva Medical, Inc. is a privately held medical device company focused on transforming vascular closure for the benefit of patients, hospitals and physicians in the over 5.5 million catheter-based coronary, peripheral and electrophysiology procedures in the United States that require access site closure each year.
The Company’s VASCADE® vascular closure system has been PMA-approved by the FDA since 2013 and is indicated for vessel closure following 5-7F arterial and venous procedures. VASCADE® is the only marketed closure system to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care in a prospective, randomized, controlled clinical trial called RESPECT.
The latest product in the Company’s portfolio is VASCADE® MVP Venous Vascular Closure System, the only marketed vessel closure technology with an indication to address electrophysiology procedures – and clinically proven by electrophysiologists in a multi-center, randomized, controlled clinical trial called AMBULATE. VASCADE® MVP received PMA approval in late 2018.
Cardiva has won numerous recent awards for clinical, commercial and operational excellence – including the Shingo Bronze Medallion. The Company is headquartered in Santa Clara, California.
For further information, visit our website at www.cardivamedical.com. VASCADE® and Cardiva Catalyst® are registered trademarks of Cardiva Medical®, Inc.
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