News | Atrial Fibrillation | August 04, 2020

Study Evaluates Location Sensor Technology to Improve AFib Ablation Guidance

New version of Abbott TactiFlex catheter uses magnetic sensors to determine the precise location inside the heart to improve ablation effectiveness

The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

August 4, 2020 — Abbott announced the first enrollments in the TactiFlex PAF  investigational device exemption (IDE) study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF). The study will evaluate the performance of the investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) for people whose atrial fibrillation (AFib) symptoms are unable to be managed by medication.

The TactiFlex PAF IDE study will enroll 355 patients at multiple sites worldwide. Patients enrolled in the trial will receive an ablation procedure using Abbott's TactiFlex Ablation Catheter, SE. Data collected from the study will be submitted to support global regulatory approvals.

Physicians use tools, such as contact force technology, during ablation procedures to help them apply the right amount of pressure to the heart tissue to improve procedural effectiveness. Additionally, physicians use magnetic sensor enabled technology, such as the TactiCath Contact Force Ablation Catheter, Sensor Enabled, for precise location and navigation within the heart.

"The TactiFlex device builds on prior generations of successful technology, giving me confidence that Abbott will continue providing options to effectively treat people living with recurrent episodes of atrial fibrillation," said Prof. Prash Sanders, director of Centre for Heart Rhythm Disorders at The Royal Adelaide Hospital in Adelaide, South Australia.

The start of the TactiFlex PAF IDE trial is among a series of product-focused activities from Abbott designed to better meet the needs of electrophysiology. The company recently secured U.S. Food and Drug Administration (FDA) and CE mark approval for the EnSite LiveView Dynamic Display. LiveView is designed to allow data from the Advisor HD Grid mapping catheter to be visualized in real time during cardiac ablation procedures. The Advisor HD Grid catheter is designed to capture information often missed with traditional mapping catheters.

The TactiFlex Ablation Catheter, SE is being clinically evaluated as part of the TactiFlex PAF IDE, a global study, and is not commercially available.

About Cardiac Ablation for Atrial Fibrillation

Cardiac ablation is a minimally invasive procedure that can treat abnormally fast heartbeats by creating lesions (ablating) in small areas of heart tissue that a physician has identified as causing the arrhythmia. When physicians use catheter ablation to treat cardiac arrhythmias, long flexible tubes — called catheters — are inserted into the heart to study the arrhythmia and to deliver radio frequency (RF) energy. Heat generated from the RF energy creates a scar on the tissue where the abnormal heartbeats originate; this type of ablation has become the gold standard for treating AFib. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia.

More than 16 million people globally are impacted by recurrent AFib, episodes of sporadic, irregular heartbeats when the heart's upper chambers beat out of sync with the lower chambers. People suffering from AFib face a number of challenges to their quality of life, including episodes of dizziness, fatigue and shortness of breath. Long term, they also face increased risk of stroke or heart failure.

For more information: www.abbott.com
 

Related Content

The SERF VT EFS is a groundbreaking, single-arm observational study designed to evaluate the safety and effectiveness of the Thermedical Durablate catheter to treat VT. #HRS20 #HRS2020 #heartrhythm2020
News | Ablation Systems | May 08, 2020
May 8, 2020 – Results from a first-in-human early feasibility study (EFS) using a saline enhanced radiofrequency (SER
The Affera Inc. pulsed field (PF) energy radiofrequency ablation system. First-in-human trial shows new point-by-point approach provides increased flexibility and efficiency for physicians treating arrhythmia patients. #HRS #HRS2020 #HRS20 #heartrhythm20

The Affera Inc. pulsed field (PF) energy radiofrequency ablation system.

Feature | Ablation Systems | May 08, 2020
May 8, 2020 — A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or par
Noninvasive Radioablation Offers Long-term Benefits to High-risk Heart Arrhythmia Patients
News | Ablation Systems | September 17, 2019
September 17, 2019 — Treating high-risk heart patients with a single, high dose of radiation therapy can dramatically
Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study
News | Ablation Systems | May 16, 2019
Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc.’s QDot Micro catheter...
CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study
News | Ablation Systems | May 16, 2019
CardioFocus Inc. announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3...
New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias
News | Ablation Systems | May 14, 2019
The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Ablation Systems | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beam will ablate for a noninvasive pulmonary vein isolation procedure. Varian acquires, buys, purchases Cyberheart.

A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beams will ablate for a noninvasive pulmonary vein isolation procedure to treat an arrhythmia.

Feature | Ablation Systems | May 10, 2019 | Dave Fornell, Editor
May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve