Medtronic has commenced a new clinical trial assessing the electrocardiography (ECG) Belt research system (ECG Belt) as a diagnostic tool to optimize cardiac resynchronization therapy (CRT) for patients with heart failure.
The ECG Belt, which is investigational, has not yet approved for sale in the US.
Iowa Heart Center’s Troy Hounshell has recruited the first patient in the ECG Belt for CRT Response trial at Mercy Medical Center – West Lakes in Des Moines, Iowa.
Hounshell said: “The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits.”
Initially, the prospective, randomized, interventional and investigational trial will recruit patients in 10 centers across the US.
The study will compare patients treated with CRT and ECG Belt diagnostics to patients treated with standard CRT.
Medtronic will expand the trial to additional sites across the world to complete the enrollment of 400 randomized patients.
Clinicians will evaluate the heart’s electrical activity through real-time synchronization measurements by using ECG Belt during the trial.
The ECG Belt will be applied externally to patients’ bodies, wrapped around the chest and back at the time of CRT device implant. It will help physicians guide placement of the left ventricular lead.
To further optimize the device’s programmed settings, the ECG Belt will be used again at follow-up visits.
CRT is a proved treatment option for indicated patients with heart failure in which an implantable device sends low levels of energy via thin wires, known as leads, to stimulate the lower chambers of the heart to enhance its pumping efficiency.
The therapy was showed to improve survival and quality of life, in addition to reducing hospitalizations.
Medtronic cardiac rhythm and heart failure division’s cardiac resynchronization therapy business general manager and vice president Dr Kweli Thompson said: “Our goal for this study is to give clinicians real-time insights to address each patient’s needs, and to help optimize CRT for heart failure patients.”
Medtronic provides CRT devices such as MR-conditional CRT-Ds and CRT-Ps and mechanical circulatory support therapy for advanced heart failure patients.