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Cardiva Enrolls First Patients in AMBULATE Trial for AFIB

The Santa Clara, CA-based company said the AMBULATE Same-Day Discharge will enroll 150 patients in up to 10 centers to evaluate the VASCADE MVP Venous Vascular Closure System.

Cardiva Medical has enrolled the first patients in a multi-center study designed to evaluate same-day discharge for patients undergoing cardiac ablation procedures for atrial fibrillation.

The AMBULATE Same-Day Discharge will enroll 150 patients in up to 10 centers to evaluate the Vascade MVP Venous Vascular Closure System, which received FDA approval in late 2018. Vascade MVP is 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 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 to 20 minutes and bedrest time by up to 4 hours,” Zayd Eldadah, MD, PhD, Principal Investigator and Director of Cardiac Electrophysiology at the MedStar Health System in Washington DC and Baltimore, said in a release. “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.”

Late last year, Cardiva Medical made MD+DI’s list of  20 Private Medtech Companies to Watch in 2020. And early last year, Canaccord Genuity's Jason Mills called attention to Cardiva saying the company’s pivotal trial results were compelling, with the Vascade MVP vascular closure system delivering a statistically significant improvement in time to ambulation; total procedure time; time to discharge eligibility; and time to hemostasis compared to manual compression.

 

TAGS: R&D
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