Boston Scientific begins NAVIGATE X4 clinical trial


Boston Scientific has announced that it has conducted the first implant in the NAVIGATE X4 clinical trial of the next generation Acuity X4 left-ventricular (LV) pacing leads and Reliance 4-Front defibrillation (ICD) leads. The clinical trial is designed to establish the safety and effectiveness of both lead families and is intended to support US Food and Drug Administration (FDA) approval of these devices.

The first patient enrolments occurred this week at Wheeling Hospital in Wheeling, USA, with Maninder Bedi, and at Central Baptist Hospital in Lexington, USA, with Aaron Hesselson. “The Acuity X4 portfolio allowed me to choose a lead that matched the patient’s anatomy,” says Hesselson.

Bedi noted the advantages of the Acuity X4 portfolio for his patient: “This patient may have otherwise had to go for an epicardial lead due to the lack of placement options, but the X4 lead got into several branches of a narrow anatomy that other leads may not have been able to access.”

A company press release states that the Acuity X4 LV leads are quadripolar leads engineered to maximise effectiveness and minimise unnecessary patient interventions after implant. The unique three-dimensional spiral design is intended to minimise floating electrodes resulting in better electrical performance; in addition, dual-fixation zones and the 2.6 French crossing profile are designed to optimise lead stability and reduce the risk of dislodgement. When an Acuity X4 lead is connected to a Boston Scientific X4 CRT-D, the resulting 17 pacing vector options are designed to improve physicians’ ability to manage unexpected complications electronically through programming rather than an invasive lead revision.

The Reliance 4-Front ICD lead is designed for reliability and performance over the long-term, the company release adds. The lead maintains the same design principles as the Endotak Reliance lead, yet offers improved handling and maneuverability.

The NAVIGATE X4 trial is a prospective, non-randomised, multicentre, global clinical study designed to support FDA approval. The two principal investigators are Suneet Mittal, director, Electrophysiology, Valley Health System, Bergen County, USA, and Martin C Burke, professor of medicine and director, Heart Rhythm Center, University of Chicago Medical Center, Chicago, USA.

The trial is expected to enrol between 1,542 and 2,290 patients at up to 125 centres in the United States, Canada and Israel. The Acuity X4 and Reliance 4-Front leads will be connected to commercially-available Boston Scientific X4 CRT-D devices.

The AcuityX4 left ventricular pacing leads and Reliance 4-Front defibrillator leads are CE-marked. In the United States, they are investigational devices and not available for sale.