A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported completion of enrollment in the Multi-center Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). The trial includes 1,820 patients and examines the potential benefits of the company's cardiac resynchronization therapy defibrillators (CRT-Ds) in a new population of heart failure patients.
Following the MADIT, MADIT II and COMPANION trials, MADIT-CRT is sponsored by Boston Scientific's cardiac rhythm management group.
The company said the trial is designed to test whether CRT-Ds can slow the progression of heart failure in heart attack survivors and in those with other forms of impaired heart function. It said that the trial may demonstrate if earlier CRT-D therapy can slow a patient's progression from early-stage heart failure (New York Heart Association as Class I and II) to Class III and IV.
"This study builds on the observations made in the COMPANION trial, which evaluated the benefits of CRT-D therapy in patients with late-stage, symptomatic heart failure," said Arthur Moss, MD, principal investigator of MADIT-CRT. It could address, he said, the still-unanswered question about the potential of resynchronization defibrillator therapy to inhibit the clinical progression of heart failure through earlier intervention.
About 70% of all heart failure patients fall into Class I or II. Nearly 22 million people worldwide, including about 5.5 million Americans, suffer from some form of heart failure.