News | Atrial Fibrillation | February 06, 2024

Cortex Announces RESOLVE-AF Trial Evaluating Electrographic Flow (EGF) Mapping for use in Atrial Fibrillation Ablation

EGF Mapping system aims to improve patient outcomes by enabling precise and personalized ablation strategies

EGF Mapping system aims to improve patient outcomes by enabling precise and personalized ablation strategies

Getty Images


February 6, 2024 — Cortex announced the initiation of its RESOLVE-AF trial (NCT05883631), a study formally launched in late October 2023. The international, multi-center trial will provide clinical evaluation of Cortex's 510(k) cleared Ablamap System with electrographic flow (EGF) and newly released Ablacath Mapping Catheter basket mapping catheter to identify extra-pulmonary vein EGF sources. EGF mapping allows physicians to detect EGF sources and is designed to individualize ablation strategies based on underlying pathophysiologic mechanisms to potentially improve outcomes. This trial aims to demonstrate that EGF mapping can be used to identify EGF sources outside the pulmonary veins in all types of patients, including those with paroxysmal, persistent, and long-standing persistent AFib and undergoing de novo or redo procedures.

AFib is the most common heart rhythm disorder, affecting more than 30 million patients worldwide. No consensus currently exists regarding the optimal treatment of persistent AFib patients. There is a significant need for efficient, targeted ablation strategies in patients where pulmonary vein isolation (PVI) alone falls short—an increasingly common scenario. "The Ablamap System's EGF mapping has the potential to provide a much-needed solution for identifying extra-pulmonary vein sources of AF," said Dr. David Haines, Principal Investigator of the RESOLVE-AF study and Director of the Heart Rhythm Center at Corewell Health in Royal Oak, MI. "By guiding ablation therapy, [EGF mapping] can enable clinicians to provide personalized, highly targeted treatment."

The RESOLVE-AF trial has been successfully enrolling patients at several centers in the U.S. and may enroll up to 400 subjects across 20+ centers in the US and Europe. It builds on the recently completed randomized, controlled FLOW-AF trial (NCT04473963), which demonstrated that EGF-guided treatment of AFib sources in persistent AFib patients improved freedom from AFib at one year post-ablation by 51% on an absolute basis compared with patients randomized to control, who received conventional pulmonary vein isolation therapy only. The Ablamap System includes a workstation with software and monitor, amplifier, and proprietary basket mapping catheter and cables. "I appreciated the simplicity of the system and the insight it provides during complex redo AFib cases," said Dr. Wilber Su, Director of Cardiac Electrophysiology at Banner-University Medical Center and Associate Professor of Medicine at the University of Arizona.

Initial clinical experience and case presentations using the Ablamap system will be presented by Dr. Kent Nilsson, Dr. David Haines, and Dr. Wilber Su at the upcoming AF Symposium.

For more information: www.cortex.co


Related Content

Videos | Cardiovascular Clinical Studies

As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits ...

Home June 12, 2024
Home
News | Cardiovascular Clinical Studies

June 6, 2024 —Cleveland Clinic researchers found higher amounts of the sugar alcohol xylitol are associated with ...

Home June 06, 2024
Home
News | Cardiovascular Clinical Studies

May 31, 2024 — CareDx, a leading precision medicine company focused on the discovery, development, and commercialization ...

Home May 31, 2024
Home
News | Cardiovascular Clinical Studies

May 29, 2024 — Data was presented by AstraZeneca on AZD0780, an oral PCSK9 inhibitor which demonstrated significant LDL ...

Home May 29, 2024
Home
News | Cardiovascular Clinical Studies

May 23, 2024 — A newly-published peer-reviewed study in the Journal of the American Heart Association, JAHA, found that ...

Home May 23, 2024
Home
News | Cardiovascular Clinical Studies

May 23, 2024 — Global Heart Hub, the international alliance of heart patient organizations, announced the first findings ...

Home May 23, 2024
Home
News | Cardiovascular Clinical Studies

May 21, 2024 — A new research paper was published in Aging (listed by MEDLINE/PubMed as "Aging (Albany NY)" and "Aging ...

Home May 21, 2024
Home
News | Cardiovascular Clinical Studies

May 20, 2024 — Cardiologist Brendan Carry, MD, and a team of Danville, PA-based Geisinger Medical Center physicians have ...

Home May 20, 2024
Home
News | Cardiovascular Clinical Studies

May 18, 2024 — Boston Scientific Corporation today announced positive six-month results from the ongoing pivotal MODULAR ...

Home May 18, 2024
Home
Subscribe Now