The REVAMP Clinical Study is a feasibility study in heart failure with preserved ejection fraction (HFpEF) patients who have normal to small left ventricular volumes and evidence of hypertrophy. The pacemaker Sleep function will be used in order to deliver a 5 hour block of sustained pacing at 100 bpm during the night for 4-8 weeks. The purpose is to investigate whether this elevated pacing therapy is tolerated and whether there is a signal of efficacy.
If tolerated the idea is that this will promote LV dilation, which will reduce stiffness in the heart and improve diastolic filling in HFpEF patients that have thickened ventricular walls.
The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. It will be a randomized, single blind (subject) trial. Subjects will be followed for two years and then annually for 3 years for a total of 5 years after implantation.