News | April 09, 2015

Medtronic Enrolls First Patient in GOLD AF Registry Study

Study will explore procedural use and treatment outcomes with Medtronic’s Phased RF ablation technology in treating atrial fibrillation

Medtronic, GOLD AF Registry, PVAC GOLD, atrial fibrillation, ablation catheter

April 9, 2015 — Medtronic plc announced the first patient enrollment in the GOLD AF Registry, a prospective, observational clinical study of its Phased Radiofrequency (RF) Ablation technology for treating patients with symptomatic atrial fibrillation (AF). The multicenter registry will provide real-world insights into the procedural use and treatment outcomes of the Pulmonary Vein Ablation Catheter (PVAC) GOLD, multi-electrode ablation catheter and other catheters that comprise Medtronic's Phased RF technology.

The Medtronic Phased RF System is a generator and endocardial catheter system that delivers customized RF energy to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain AF. The system is not approved in the United States, but is under investigational device exemption (IDE) study in the VICTORY AF clinical trial.

"The GOLD AF Registry will give us the opportunity to further evaluate and uncover best practices for treating patients with Phased Radiofrequency technology," said L.V.A. Boersma, M.D., cardiologist at St. Antonius Ziekenhuis Nieuwegein, The Netherlands. "We'll be able to review data - in a very large patient cohort - on the PVAC GOLD catheter, which maps, ablates and validates pulmonary vein isolation quickly. Pulmonary vein isolation is a clinically effective therapy for treating symptomatic AF patients, and the goal of the PVAC GOLD catheter is to allow physicians to effectively isolate the veins."

The GOLD AF Registry will assess treatment by PVAC GOLD ablation of patients with paroxysmal (occasional) or persistent AF, lone AF or AF with underlying disease, and provide data on acute and mid-term success rates, as well as other procedural details and patient characteristics. It will enroll up to 1,000 patients at 50 sites in 11 countries. Patients will be observed for 12 months following a Phased RF procedure.

The PVAC GOLD catheter features improved thermal efficiency of gold electrodes, compared to the platinum electrodes of the first-generation system, to help physicians optimize RF ablation therapy. By delivering RF energy through nine electrodes (either all simultaneously or a subset of electrodes), the PVAC GOLD catheter helps physicians safely and efficiently create consistent lesions (intentional scar in the tissue) to effectively block the erratic AF electrical currents coming from the pulmonary veins. The gold electrodes provide four times the thermal conductivity of their platinum predecessors, offering the potential for more accurate temperature measurement and improved power delivery.

The catheter features an over-the-wire design and an anatomic shape to help physicians safely position and stabilize the catheter in different patient anatomies. A forward-tilted array helps physicians find optimal placement that is designed to improve uniformity of contact with the tissue. Following ablation, the catheter is capable of verifying PV isolation through its ability to pace and map.

For more information:

Related Content

FDA Approves TactiCath Contact Force Ablation Catheter, Sensor Enabled
Technology | Ablation Systems | January 21, 2019
Abbott announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter,...
First Patient Treated in STELLAR Atrial Fibrillation IDE Study
News | Ablation Systems | November 30, 2018
Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first...
FDA Approves Biosense Webster's Tag-Index Guided Ablation Software
Technology | Ablation Systems | October 09, 2018
Biosense Webster Inc. recently received approval from the U.S. Food and Drug Administration (FDA) for its Visitag...
Medtronic Cryoballoon Improves Quality of Life, Reduces Systems of Persistent Atrial Fibrillation
News | Ablation Systems | August 28, 2018
Medtronic plc announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life...
Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Overlay Init