Biotronik launches 2 new studies

Biotronik announced 2 new studies last week that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor.

A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said.

Biotronik said the trial will be the 1st to investigate defibrillator back-up following device placement in heart failure patients with a primary indication for cardiac resynchronization therapy defibrillators.

Patients in the trial will be implanted with Biotronik’s CRT-Ds and assessed for the rate of ventricular tachyarrhythmias over 2 years. Biotronik said that it looks to evaluate the risk of VTA or ventricular fibrillation after replacement, with a primary endpoint being the number of patients with at least one sustained VTA or VF.

“Eighty percent of ICD patients implanted for primary prevention do not experience a VTA during the lifetime of their first device. 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,” coordinating clinical investigator Dr. Daniel Gras of Nantes, France’s Nouvelles Cliniques Nantaises said in a press release.

Another trial, the BioGuard MI1 study, will examine the effectiveness of Biotronik’s BioMonitor at reducing the likelihood of major adverse cardiovascular events in patients with relatively preserved ejection fraction who have experienced myocardial infarction. The study has already enrolled its 1st patient, Biotronik said.

The company’s BioMonitor is a leadless cardiac monitor implanted under the skin to track cardiac electric activity and provide remote monitoring of patients with arrhythmias, the company said.

The controlled, randomized trial is slated to enroll 2,900 patients at 35 centers worldwide, the company said.

The primary goal of the study is to examine an underrepresented group of patients with preserved left ventrical ejection fractions after AMI events, and investigate if the BioMonitor’s arrhythmia predictions are as useful for them as it has shown to be for patients with lower LVEF, the company said.

“From previous study results, we already know just how important cardiac arrhythmia can be as an indicator of further critical events in heart patients. The question now, which we hope to address with the BioGuard MI study, is whether highly accurate and reliable monitoring tools like BioMonitor with home monitoring, can help us identify early warning signs, thereby leading to faster treatment while minimizing direct interference in patients’ lives,” said coordinating clinical investigator Christian Jons of Copenhagen’s Rigshospitalet Heart Center said in a prepared statement.

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