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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

View the latest clinical trials, studies, data, and updates.

Biosense Webster Completes Enrollment in Pivotal Trial Evaluating PFA and RF Dual Energy Catheter for Patients with Atrial Fibrillation in Europe

Biosense Webster reported SmartfIRE is a pivotal, prospective, multi-center, single-arm study evaluating Biosense Webster’s dual energy pulsed field and radiofrequency ablation system. Since the study’s commencement in February 2023, the trial has enrolled 149 patients with paroxysmal AFib across nine centers in Europe. Patients will be assessed for 12 months for safety and efficacy.

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Elixir Medical Completes Enrollment in INFINITY-SWEDEHEART Clinical Trial of DynamX™ Coronary Bioadaptor System

The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is part of the ongoing Swedeheart registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for coronary heart disease.

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Vascular Stent iliofemoral Study

Gore announces First U.S. Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study

The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia. “With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial,” he said.

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