News | August 18, 2014

Clinical Trial at Mission Health Studies New Way to Treat Persistent Atrial Fibrillation

August 18, 2014 — A clinical trial being conducted at Mission Health using Medtronic's Phased Radiofrequency (RF) ablation system, may one day help people with persistent atrial fibrillation that does not respond to medication.

The trial, known as VICTORY-AF (which stands for Evaluation of Multielectrode Phased RF Technology in Persistent AF), is what is known as a prospective, non-randomized study. In essence, patients who present to their doctor with a certain set of criteria outlined by a clinical trial protocol are eligible to receive treatment with this device. In this study, patients with persistent or long-standing persistent atrial fibrillation (AF) undergo an ablation procedure with a the phased RF system.

In the United States, ablation catheters currently are available only for treating the mildest form of AF in which the heart's upper chambers beat rapidly and irregularly during episodes lasting from a few minutes to a few days. AF can progress into a persistent or long-standing persistent state, where patients do not respond to the drugs typically used to control this condition. Patients with persistent and long-standing persistent AF can have debilitating symptoms and are increased risk for stroke and hospitalizations, and can experience a reduced quality of life.

Persistent AF is defined as sustained AF lasting more than seven days but less than one year, or lasting fewer than seven days but requiring cardioversion through medication or electrical current. Long-standing persistent AF is defined as continuous AF lasting more than one year but fewer than four years.

Joseph Souza, M.D., director of the cardiac electrophysiology laboratory at Mission Hospital, leads the clinical trial in western North Carolina. Mission Health is one of only two centers in North Carolina participating in this trial, and the only one to date that has used the device. In total, 40 centers throughout the United States, Canada and Europe participate in the VICTORY-AF clinical trial. About 300 patients will be treated in the trial — 200 of those will come from the U.S. Mission Health has the second highest number of enrollments in the VICTORY-AF trial in the country.

What is special about this catheter, said Souza, is that previous trials on this device have refined the number of individual catheters needed, and found that those that had gold tips work better than previous versions that were tipped with platinum.

“With these trials,” said Souza, “we can get our hands on something that is an improvement over traditional catheters used in this procedure. Trials can get us closer to solving common problems for which we have limited solutions.”

“Trials can advance the practice of medicine by not only introducing new devices into wide use, but can provide better outcomes for patients — not only in relation to the devices themselves, but by improving safety, cutting down on repeat procedures and sometimes the amount of time the patient needs to be under anesthesia. They often offer cost savings in other ways,” Souza adds.

To date, Souza has used the device in three patients. Several other good candidates have also been identified.

The Medtronic Phased RF System is currently approved for use in areas of Europe, Asia, Africa, Australia and Canada. More than 20,000 patients in 26 countries have been treated with this system since January 2009.

Souza has participated in or directed clinical trials at Mission since 1998.

For more information: mission-health.org, www.medtronic.com

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
Overlay Init