News | Heart Failure | March 01, 2016

Ohio State Evaluates First Transcatheter Diastolic Heart Failure Implant

Trial will enroll total of 40 patients at 28 sites worldwide
 

interatrial shunt, diastolic heart failure, DHF, Wexner Medical Center Ohio State, first patient enrolled

March 1, 2016 — For the first time in the United States, a clinical trial is underway that’s evaluating a device designed to treat diastolic heart failure. The first patient enrolled in the randomized, blinded study is being treated at The Ohio State University Wexner Medical Center.

Diastolic heart failure (DHF) occurs when the heart muscle becomes stiff and doesn’t relax enough to allow blood to flow from the lungs into the heart. This causes blood to back up in the lower left chamber, then the upper left chamber and into the lungs, causing shortness of breath.

“Over the last few decades, we’ve tried many therapies that we’ve used with systolic heart failure — a condition when the heart doesn’t contract strongly enough to push blood out to the body. None of these therapeutic options have worked for DHF, thus we can only try to manage the symptoms of DHF with diuretics,” said Rami Kahwash, M.D., a cardiologist and the study investigator at The Ohio State University Richard M. Ross Heart Hospital.

Kahwash and Ohio State cardiologist Scott Lilly, M.D., are part of a multi-center study that’s evaluating a dime-size implant intended to relieve the high pressure created by blood backing up from the heart into the lungs. During a heart catheterization, doctors create a small path between the left and right upper chambers of the heart. They insert the tiny, inter-atrial shunt device to keep the path open to divert some of the blood from the high pressure left atrial chamber to the low pressure right atrial chamber. This could potentially lower the pressure in the left upper chamber, decrease the pressure in the lungs and thereby improve the symptoms of heart failure.

“It’s just like when you have a traffic jam. Instead of backing up all the way back to the lungs, we’re creating a detour that’s taking the blood around another route and relieving the pressure,” Kahwash said.

That’s exactly what Janet Wickham of Senacaville, Ohio, was hoping for when she volunteered for the trial. Neither she nor the doctors will know whether she got the device until the study is complete. The 69-year-old tries to stay active, but she says having DHF means sometimes it’s hard to leave her house.

“You can’t breathe, you can’t move, you just can’t function. I want to feel better, so if there’s something new I want to try it. I’m just taking a chance,” Wickham said.

Kahwash said finding new treatment options for DHF is crucial because it’s a growing public health problem. Risk factors include high blood pressure, diabetes, obesity and age. Kahwash said it’s estimated that within the next five years, DHF will account for more than half of all heart failure cases, and be responsible for more hospital admissions than systolic heart failure.

The transcatheter interatrial shunt device is made by Corvia Medical Inc., which is funding the randomized trial. In all, 40 DHF patients will be randomized at up to 28 sites around the world.

For more information: www.wexnermedical.osu.edu

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on HeartFlow FFRct Analysis
News | FFR Catheters| August 09, 2017
HeartFlow Inc. announced that four Blue Cross Blue Shield companies have each issued a positive medical policy for the...
Overlay Init