Alleviant’s No-Implant Interatrial Shunt Device to Treat Heart Failure Patients Evaluated in Multicenter Clinical Data

May 20, 2022—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that results from early clinical evaluation of the Alleviant system (Alleviant Medical, Inc.) for the treatment of heart failure patients with preserved and reduced ejection fraction (HFpEF and HFrEF) demonstrated procedural safety and feasibility, with a promising efficacy signal through 6 months. The multicenter evaluation was conducted across three trial programs: ALLEVIATE-HF-1, ALLEVIATE-HF-2, and ALLEVIATE-HFrEF.

The transcatheter Alleviant system is intended to reduce pressure within the left atrium through the creation of a therapeutic interatrial shunt, without a permanent cardiac implant or open heart surgery, noted SCAI.

The findings were presented as late-breaking clinical research at the SCAI 2022 scientific sessions held May 19-22 in Atlanta, Georgia.

According to SCAI, the study included patients aged ≥ 40 years and New York Heart Association class II, III, or ambulatory IV with elevated peak exercise pulmonary capillary wedge pressure (PCWP). Baseline screening included echocardiography, exercise right heart catheterization, Kansas City Cardiomyopathy Questionnaire (KCCQ), and 6-minute walk test.

After transseptal puncture, the Alleviant device was inserted through the femoral vein, advanced to the heart, and supplied with a short pulse of radiofrequency energy to remove a segment of the interatrial septum. Procedures were performed under fluoroscopic and echocardiographic guidance.

The SCAI press release reported that 31 patients have been followed through 3 months and 15 patients through 6 months. Mean peak exercise PCWP decreased from baseline to 1 month across all studies. A significant increase in KCCQ overall summary score was observed at 6 months in the HF-1 study and at 3 months in the HF-2 and HFrEF studies.

Echocardiography confirmed that all shunts evaluated remained patent at 1, 3, and 6 months. Additionally, 10 patients have completed 1-year follow-up with confirmed shunt patency. The investigators and research team will continue to evaluate the Alleviant system as they collect ongoing follow-up data, advised SCAI in the press release.

The study’s lead author is Colin M. Barker, MD, Director of the Cardiac Cath Lab at Vanderbilt University Medical Center in Nashville, Tennessee.

Dr. Barker commented in the SCAI press release, “Unfortunately, we know that this group of heart failure patients currently has limited treatment options. [These] early data [are] promising and show that we are headed down the right path in developing a new, safe, and effective approach, without the burden of an implant, to help address the unique needs of this large and underserved patient population.”

The SCAI press release noted that Alleviant Medical is preparing to sponsor a large, multinational, prospective, randomized, sham-controlled trial on its no-implant interatrial shunt device in the treatment of HFpEF patients. Recruitment is anticipated to begin later in 2022.

SCAI further stated that outcomes from the recently published REDUCE LAP-HF II pivotal study underscore the importance of appropriate patient selection and have informed the design of the company’s forthcoming pivotal study. Professor Sanjiv J. Shah, MD, et al published the primary results from REDUCE LAP-HF II in The Lancet (2022;399:1130-1140).