Ohio State University Launches First-in-World Clinical Trial of Heart Failure Device, In a groundbreaking initiative, the Ohio State University Wexner Medical Center has embarked on the world’s inaugural clinical trial featuring a novel heart failure device. This innovative device, named ALT-FLOW II, aims to alleviate pressure within the left side of the heart, offering potential relief from debilitating symptoms such as breathlessness.
The ALT-FLOW II is a minuscule shunt device surgically implanted between the coronary sinus vein and the left atrium. Its purpose is to facilitate blood flow from the coronary sinus vein to the left atrium, thus effectively reducing pressure within the left side of the heart.
Ohio State University Launches First-in-World Clinical Trial of Heart Failure Device
This ambitious clinical trial is set to enroll 100 patients grappling with heart failure. Participants will be randomly assigned to undergo either the ALT-FLOW II procedure or a simulated procedure. The study’s primary endpoint revolves around assessing changes in the patients’ symptoms over a one-year period.
Leading this pioneering study are Rami Kahwash, MD, Director of Ohio State’s Heart and Vascular Research Organization, and Scott Lilly, MD, an interventional cardiologist overseeing the structural heart disease program.
Dr. Kahwash expressed enthusiasm, stating, “We are thrilled to lead the world’s first clinical trial for the ALT-FLOW II device. This device has the potential to make a profound impact on heart failure patients, and we are eager to ascertain its safety and efficacy.”
Heart failure, a chronic condition compromising the heart’s ability to pump blood efficiently, stands as a leading cause of mortality in the United States. Remarkably, no FDA-approved devices currently exist to alleviate pressure within the left side of the heart.
The ALT-FLOW II device is a product of Edwards Lifesciences, with the company also serving as the trial’s sponsor.
Anticipated to conclude in 2025, the clinical trial could potentially make the ALT-FLOW II device accessible to patients in the United States by 2026.
Additional Insights into the Clinical Trial:
- The trial extends an invitation to heart failure patients contending with symptoms such as shortness of breath, fatigue, and exercise limitations.
- Participants will be assigned randomly to either undergo the ALT-FLOW II procedure or a simulated procedure closely resembling it, though without actual device implantation.
- A comprehensive year-long follow-up will elucidate the device’s impact on patients’ symptoms.
This heralds a promising breakthrough for heart failure patients, as the ALT-FLOW II device holds the potential to substantially enhance their quality of life by mitigating debilitating symptoms. Stay tuned for ongoing updates as we track the progress of this trailblazing endeavor.