Dr. Marat Fudim, advanced heart failure specialist at Duke University Medical Center, presented results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data came from a roll-in cohort for the REBALANCE-HF investigational device exemption feasibility trial.
Santa Clara, California-based Axon Therapies said its data remains consistent with prior results for the SAVM therapy. The novel, frontline therapy uses an outpatient ablation procedure. It aims to rebalance volume distribution for heart failure patients with preserved ejection fraction (HFpEF).
In addition to the positive results, Axon Therapies said it expects its trial to reach full enrollment by the end of the month. The approximately 120-patient study should provide full results in 2024.
“The SAVM procedure offers an exciting option to treat an underlying cause of heart failure in a patient population that currently has limited treatment options available,” said Fudim. “Although early data, it is promising to see positive patient benefits sustained for six months and we look forward to further demonstrating how SAVM has the potential to benefit the HFpEF patient population.”
About the Axon Therapies REBALANCE HF trial
The trial evaluates the safety and efficacy of SAVM with the Axon Satera ablation catheter. This ablation system enables targeted ablation of the overactive sympathetic nervous system.
As an implant-free, catheter-based procedure, it aims to restore volume balance and stop disease progression while improving heart failure symptoms.
Primary endpoints for the trial include clinical improvements in pulmonary capillary wedge pressure (PCWP) with exercise and patient quality of life metrics.
The roll-in cohort includes 26 patients who successfully underwent SAVM with a strong safety profile. They showed a sustained improvement in PCWP with exercise. The subjects also demonstrated improvements in functional capacity, symptoms, and overall health status. All these improvements appeared at one month and extended to six.
Axon Therapies expects findings to inform its pivotal trial, slated to begin in late 2023.
Dr. Shanjiv Shah, national principal investigator for the trial, explained that the diversity of HFpEF may impact clinical outcomes. For that reason, the investigators opted for a larger feasibility trial. They aim to identify potential responder groups at an earlier stage, he noted.
“As we continue to collect follow-up data for the REBALANCE-HF feasibility trial, this information will help guide the final pivotal trial design,” Shah said.
Shah serves as an advanced heart failure specialist and director of research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago.