Medtronic (MDT) commences a 3,000-patient 200-site post market clinical trial to assess the superiority of cardiac resynchronization therapy (CRT) devices utilizing the AdaptivCRT feature versus standard CRT in heart failure patients. AdaptivCRT preserves normal heart rhythms and automatically adjusts to patients' needs to customized therapy.
The primary endpoint is a combination of all-cause mortality and the rate of medical intervention for decompensation (worsening heart failure). Secondary endpoints include the incidence of atrial fibrillation, quality of life measures and cost effectiveness.
Patients will receive a CRT-pacemaker or CRT-defibrillator equipped with the AdaptivCRT algorithm. They will be randomized 1:1 (aCRT on or off) and will be followed at three and six months after randomization and then every six months until the trial ends.