Medtronic has completed enrolling the first patient in MIRACLE EF clinical trial, designed to evaluate the effectiveness of its Consulta cardiac resynchronization therapy-pacemaker (CRT-P) in treating symptomatic heart failure patients with mild-to-moderate structural heart disease.
The automatic and implantable Consulta CRT-P, which features OptiVol fluid status monitoring and five pacing vectors, provides pacing to help coordinate the heart's pumping action and improve blood flow.
The controlled, double-blind, prospective, randomized clinical trial will enroll up to 2,300 patients with slightly reduced left ventricular ejection fraction (LVEF) in the range of 36 to 50%, and treat them with Consulta, which is not approved by the FDA for the patient population being studied.
Patients will be followed for at least two years or until completion of the study, which is expected to take four to five years.
The effectiveness of CRT-P in the patient population will be assessed using a composite endpoint of time to first event, defined as all-cause mortality or heart failure hospitalization, claims the company.
Karolinska University Hospital spokesperson and trial principal investigator professor Cecilia Linde said, "Previous studies have proven the real-world therapeutic benefits of CRT in treating mildly to severely symptomatic heart failure patients with moderately to severely reduced cardiac pumping capacity and electrical dyssynchrony."
Medtronic cardiac rhythm disease management business medical director and heart failure vice president and general manager David Steinhaus said the upon completion, MIRACLE EF trial will influence clinical practice guidelines regarding the use of advanced CRT devices and potentially lead to another expanded indication for the company's CRT devices.
"We look forward to the positive implications these findings could have on heart failure patients whose disease is less pronounced, yet who still experience symptoms and need advanced therapeutic solutions," Steinhaus added.
