Late-Breaking Clinical Trial Results Announced At Heart Rhythm 2016: Novel Sensor Technology Proven Safe And Effective For First Time In Large Scale Heart Failure Patient Population

New study examines performance of technology that measures patient’s cardiac muscle vibrations and significantly reduces number of hospitalizations

May 05, 2016

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Allison Kassel
BRG Communications
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Shane Osborne
Heart Rhythm Society
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SAN FRANCISCO, May 5, 2016 – The first ever trial using new SonR hemodynamic sensor technology proves to be safely and effectively applied in cardiac resynchronization therapy (CRT) patients. Early performance results from the Clinical Response to Cardiac Resynchronization Therapy with the SonR Hemodynamic Sensor: The RESPOND-CRT Randomized Trial were presented today at Heart Rhythm 2016, the Heart Rhythm Society’s 37th Annual Scientific Sessions and show reduction in hospitalizations for this patient population by 35 percent.

CRT can relieve heart failure symptoms by improving the timing of the heart’s contractions, or beats, which protects patients from abnormally slow and fast heart rhythms. Although CRT is widely used to treat many heart failure patients, one-third of patients do not benefit from this therapy. The limited response to CRT can be reduced by echocardiographic optimization of atrioventricular (AV) and interventricular (VV) intervals during therapy. This method of optimization is known to be costly and time-consuming and requires skill and expertise, so it is usually undertaken only in ‘non-responder’ patients.

SonRtip lead (LivaNova) uses a hemodynamic sensor that uniquely measures the patient’s cardiac muscle vibrations in real-time and enables individualized automatic optimization of the AV and VV delays. In doing so, these measurements are then transmitted to the CRT device, which uses them to determine the best settings for the patient. SonR is the first and only system to provide weekly automatic optimization during a patient’s real-life activities.

The RESPOND-CRT trial is a prospective, multi-center, non-inferiority study involving patients with a CRT device who were randomized to receive either the SonRtip lead or the echocardiographic optimization. A total of 1,039 patients were enrolled in 125 sites in 12 countries from three continents, including North America.

Results of the study indicate that patients receiving automatic programming using the new SonRtip lead were more likely to respond to CRT than patients using echocardiographic optimization. Specifically, there was a 75.0 percent response rate for patients using the SonRtip lead versus a response rate of 70.4 percent for patients with echocardiographic optimization. Additionally, patients using the SonRtip lead saw a 35 percent reduction in heart failure related hospitalizations. The primary efficacy non inferiority endpoint and the co-primary safety endpoints of the study were met.

“With one-third of patients not responding properly to current CRT optimization methods, we saw the need to explore alternative methods to improve patient outcomes. This new SonR technology is the first system to automatically optimize for patients every week. Importantly, it works while the patient is active and therefore provides patients with a better way of life,” said Josep Brugada, MD, PhD, Hospital Clínic de Barcelona. “This is a very promising technology for patients managing their heart failure and has the potential to become the new gold standard for CRT optimization.”

Study authors note the practical implication of this trial is to provide physicians with an alternative to echocardiographic optimization using an automated, hemodynamic-based algorithm for systematic AV and VV delays optimization. Pending additional long-term results, this approach could prove to be the superior CRT optimization method.

Sessions details:

“Clinical Response to Cardiac Resynchronization Therapy with the SonR Hemodynamic Sensor: The RESPOND-CRT Randomized Trial” [Thursday, May 5, 2016, 8:00 a.m. – 9:30 a.m. PDT, Level 3, Moscone West]

Heart Rhythm 2016 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,900 heart rhythm professionals in more than 70 countries around the world. For more information, visit www.HRSonline.org .