News | January 13, 2011

Patients Enrolled in Force-Sensing Ablation Catheter Trial

January 13, 2011 – The first patients have been enrolled in a trial evaluating the effectiveness and safety of a force-sensing ablation catheter for treating symptomatic paroxysmal atrial fibrillation (AF). The TOCCASTAR trial will study Endosense’s TactiCath force-sensing ablation catheter.

The clinical study will take place at Na Homolce Hospital, Prague, Czech Republic, by study investigator Petr Neuzil, M.D.

TOCCASTAR is a prospective, randomized, multicenter, investigational device exemption (IDE) clinical trial. Results of the study will be used to support a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for clearance of the TactiCath catheter and accompanying TactiSys system.

It will be conducted at up to 30 centers in the United States and Europe. Three hundred patients will be randomized on a one-to-one basis for treatment with the company’s force-sensing TactiCath or a catheter approved by the FDA for paroxysmal AF. The study’s primary effectiveness endpoint will measure acute procedural success as well as chronic freedom from symptomatic AF, atrial tachycardia and atrial flutter at 12 months. The safety endpoint will report the incidence of device-related serious adverse events. In addition, it will assess the contribution of real-time contact force information to procedural effectiveness during ablation compared to conventional radiofrequency (RF) irrigated catheters.

AF patients are typically treated with pharmaceutical drugs that are frequently ineffective and may cause side effects, or they undergo invasive surgery. TOCCASTAR will explore a new catheter ablation treatment option for patients who have symptomatic paroxysmal (sudden and temporary) AF and who are resistant or intolerant to at least one class I-IV antiarrhythmic drug.

“The ability of physicians to control contact force during ablation procedures has long been a missing link in catheter ablation, and the consequence of this has been an historic tradeoff between procedure safety and effectiveness,” said Vivek Reddy, M.D., TOCCASTAR principal investigator and director of the cardiac arrhythmia service, The Mount Sinai Medical Center, New York. “TOCCASTAR is a landmark study in that its results may pave the way for contact force sensing to become the new standard of care in radiofrequency catheter ablation, a development that would finally address this issue and ultimately help improve safety, effectiveness and access to the procedure.”

During catheter ablation, the electrophysiologist uses a catheter to create a series of lesions along the heart wall to disrupt abnormal electrical activity. With no way to objectively measure the contact force between the catheter tip and beating heart wall, the electrophysiologist has to estimate – and frequently guess – the level of force required. This creates a delicate balancing act between procedure effectiveness and safety, as too little force may render the procedure ineffective and too great a force may perforate the heart wall.

TactiCath is the first and only commercialized force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Launched outside of the United States in April 2010, the second-generation TactiCath is now used by electrophysiologists across Europe.

For more information: www.endosense.com

Related Content

Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems| December 08, 2017
December 7, 2017 — Stereotaxis Inc.
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems| October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems| October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems| May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems| May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems| February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems| January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems| November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Overlay Init