The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test whether early transcatheter edge-to-edge repair (TEER) in patients with heart failure and reduced ejection fraction (HFrEF) and relevant secondary mitral regurgitation, that are at risk of not receiving full guideline recommended therapy (GDMT), results in faster and more complete GDMT up-titration and whether this translates into improved quality of life and clinical outcomes.
Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)
Clinically significant functional mitral regurgitation (moderate-to severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization (i.e. EROA ≥0.2 cm² and/or regurgitant fraction >30%)
Suboptimal GDMT therapy corresponding to a GDMT score <7 points
Office systolic blood pressure <120 mmHG
Terminal heart failure or hemodynamic instability
Primary TR or MR, any other severe valvular heart disease
Untreated clinically significant CAD (coronary artery disease) requiring revascularization
LVEF <35% and left bundle branch block with a QRS duration >150 ms
University Medical Center Mainz
Lead sponsor
Abbott
Collaborator