Boston Scientific Announces First Patient Enrollment For The Septal CRT Study

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 07 Nov 2008 - 2:00 PDT

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Boston Scientific Corporation (NYSE: BSX) today announced that the first patient was enrolled in the SEPTAL CRT clinical study, sponsored by the Company's Cardiac Rhythm Management (CRM) group. The patient was enrolled in France by Prof. Christophe Leclercq MD from CHU-Hôpital Pontchaillou, Rennes.

SEPTAL CRT is a prospective, randomised trial designed to investigate the long-term clinical efficacy and patient outcomes of placing a right ventricular defibrillator lead in different areas of the heart for patients implanted with a Boston Scientific cardiac resynchronisation defibrillator (CRT-D). Patients will be implanted with a RELIANCE® G or SG defibrillator lead, which will be randomised for placement in either the apex of the right ventricle or in the mid-septum. Patient outcomes will be measured using several variables including evaluation of heart function by echocardiography.

"The placement of the right ventricular lead for CRT patients remains controversial," said Prof. Christophe Leclercq MD, CHU-Hôpital Pontchaillou, Rennes, France, and Principal Investigator of the study. "We can hypothesise that the mid-septal location, closer to the conduction system, could improve the efficacy of CRT therapy and thus might have a significant impact on clinical outcome. The SEPTAL CRT trial is designed to answer this crucial question with the comparison of apical and mid-septal RV lead locations."

"The SEPTAL CRT study is another example of how Boston Scientific is dedicated to providing evidence-based guidance to aid physicians in selecting optimal treatments for their patients," said Ulrich Michel, Vice President Safety and International Clinical Operations for Boston Scientific CRM.

The patient selection criteria for SEPTAL CRT allows inclusion of patients with chronic heart failure who are on optimal and stable medication and are undergoing their first implant with a Boston Scientific CRT-D device and a RELIANCE G or SG lead. The study will include up to 416 patients in centres in France and Spain.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific-international.com.

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Boston Scientific Corporation