News | June 15, 2012

Endosense Completes Enrollment in FDA Study of Force-Sensing Ablation Catheter

June 15, 2012 —Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment completion in the TOCCASTAR clinical study. TOCCASTAR is a prospective, randomized, multi-center investigational device exemption (IDE) trial designed to evaluate the safety and effectiveness of the company’s TactiCath force-sensing ablation catheter in patients with symptomatic paroxysmal atrial fibrillation (AF).

TOCCASTAR study investigators enrolled 300 patients at 17 centers across the United States and Europe. All patients were randomized on a one-to-one basis for treatment with the TactiCath or a control radiofrequency catheter approved by the U.S. Food and Drug Administration (FDA) for treating paroxysmal AF.

The TOCCASTAR study will evaluate the safety and effectiveness of the TactiCath based on 12-month follow-up data from the index procedure. The primary effectiveness endpoint is a non-inferiority comparison of treatment success as defined by both acute procedural success and chronic freedom from symptomatic paroxysmal AF, atrial tachycardia and atrial flutter; the safety endpoint is a non-inferiority comparison of early onset device-related serious adverse events. Secondary endpoints include a superiority comparison of procedural effectiveness related to the use of the contact-force sensor.

“Contact-force sensing in the context of a radiofrequency ablation catheter represents a significant enhancement to the tools available to electrophysiologists treating AF. The idea that we can deliver intra-cardiac lesions will full knowledge of the quality of the electrode-tissue interface is very appealing,” said Vivek Reddy, M.D. TOCCASTAR principal investigator and director of the Cardiac Arrhythmia Service, The Mount Sinai Medical Center, New York. “When complete, TOCCASTAR will provide the first randomized comparison of treatment safety and success between a conventional radiofrequency catheter and one with contact-force sensing capability. Through the use of this important diagnostic feature, we are gaining singular insights into the challenges and techniques that define optimal cardiac ablation therapy.”

Endosense expects to use the results of the TOCCASTAR study to support a premarket approval application (PMA) to the FDA in the third quarter of 2013.

 


Related Content

News | Cardiovascular Clinical Studies

April 20, 2023 — Researchers led by Northwestern University and the University of Texas at Austin (UT) have developed ...

Home April 20, 2023
Home
News | Cardiovascular Clinical Studies

April 5, 2023 — Acarix, a leader in acoustic and AI-based cardiac diagnostics, announced the release of a new study ...

Home April 05, 2023
Home
News | Cardiovascular Clinical Studies

March 29, 2023 — Irregular sleep patterns may play a role in the pathophysiologic development of cardiovascular disease ...

Home March 29, 2023
Home
News | Cardiovascular Clinical Studies

March 27, 2023 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and ...

Home March 27, 2023
Home
News | Cardiovascular Clinical Studies

March 24, 2023 — Vaxxinity, Inc., a Cape Canaveral, FL-based company pioneering the development of a new class of ...

Home March 24, 2023
Home
News | Cardiovascular Clinical Studies

March 22, 2023 — Ancora Heart, Inc., a privately-held Santa Clara, CA-based company developing a completely ...

Home March 22, 2023
Home
News | Cardiovascular Clinical Studies

March 21, 2023 — The first platform to combine real-world cardiology data from millions of people in multiple European ...

Home March 21, 2023
Home
News | Cardiovascular Clinical Studies

March 13, 2023 — BioCardia, Inc., developer of cellular and cell-derived therapeutics for the treatment of ...

Home March 13, 2023
Home
News | Cardiovascular Clinical Studies

March 8, 2023 — A unique community-based partnership, the African American Heart Study, will be conducted to measure the ...

Home March 08, 2023
Home
News | Cardiovascular Clinical Studies

March 6, 2023 — A multifaceted intervention to improve prescribing practices increased the likelihood that patients with ...

Home March 06, 2023
Home
Subscribe Now