BIOTRONIK Announces Start of First Study to Assess Relevance of Defibrillator Back-Up after CRT-D Replacement

(PresseBox) (Berlin, Germany, ) BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the first patient has been enrolled in the BioCONTINUE clinical trial (BIOtronik study to assess the CONTINUation of Existing risk of ventricular arrhythmias after CRT-D replacement). BioCONTINUE is the first study to investigate the relevance of defibrillator back-up following first device replacement in a heart failure (HF) patient population with a primary indication for a cardiac resynchronization therapy defibrillator (CRT-D).

The decision to replace a CRT-D with either another CRT-D or a CRT device without defibrillator back-up (CRT-P) depends on several factors. One important aspect is that near normalization in left ventricular ejection fraction (LVEF) induced by CRT is associated with a significant reduction in the subsequent risk of life-threatening VTA. This creates concerns about implantable cardiac-defibrillator (ICD) indication, as many former CRT-D patients could be eligible for replacement with a CRT-P.

"80 percent of ICD patients implanted for primary prevention do not experience a VTA during the lifetime of their first device1," stated coordinating clinical investigator Dr. Daniel Gras, Nouvelles Cliniques Nantaises, Nantes, France. "In addition, if these HF patients successfully respond to CRT during their initial device's lifetime, they may no longer be indicated for defibrillator back-up by the time it is due for replacement. However, even if a patient no longer fulfills the criteria for a defibrillator at the time of CRT-D replacement, the risk of subsequent ventricular arrhythmia could remain. Our goal is to create a risk mapping profile according to individual patient characteristics to assist physicians in making this complex decision."

In order to evaluate the subsequent risk of VTA after CRT-D replacement according to individual patient characteristics, BioCONTINUE will enroll 277 patients in 40 centers in eight countries worldwide. All patients will be implanted with BIOTRONIK CRT-Ds, and have a minimum follow-up period of two years. The trial's primary endpoint is the number of patients with at least one sustained VTA or ventricular fibrillation (VF). The association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent ventricular tachyarrhythmia will be explored in a subgroup analysis.

"By observing this specific population, BioCONTINUE will provide key insights into the relevance of defibrillator back-up, especially for patients with improved LVEF and an event-free first CRT-D service life," commented Albert Panzeri, Vice President at BIOTRONIK. "Our mission at BIOTRONIK is to save patients' lives and improve their quality of life. Therefore, BIOTRONIK has a long history of sponsoring landmark clinical trials like BioCONTINUE, which expand clinical knowledge of which therapies and devices best accomplish that. We eagerly look forward to the results."

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1 Van Welsenes GH, et al. Europace. 2011, 13.


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