Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Inclusion Criteria:

• Informed consent
• Age > 40 years
• LVEF > 45% documented within the last 3 months.
• NYHA class ≥II status or 6MWT distance <80% predicted.
• Left atrial enlargement
• PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.
• Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic monitoring.

Exclusion Criteria:

• Recent MI, PCI or CABG
• Untreated CAD with indication for revascularization
• Recent stroke, pulmonary embolism or major surgery
• Uncontrolled atrial fibrillation
• H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease
• Inability to perform a 6-minute walk test.
• Clinically significant valvular disease
• Uunsuitable for study participation at investigator discretion.
• Severe COPD, Anemia or morbid obesity
• Uncontrolled hypertension
• Women of child bearing age
• RA pressure >15 mmHg or PVR >4 wood units